Data / Medical devices / United States / Straumann USA, LLC
Straumann USA, LLC: FDA-registered device maker in Andover, MA, United States, 1 510(k) clearance
Straumann USA, LLC is registered with the FDA (registration 1222315) in Andover, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 19, 2025. 36 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1222315
- FEI number
- 1000121052
- Address
- 60 Minuteman Rd, Andover, MA, United States, 01810
- Owner or operator
- INSTITUT STRAUMANN AG (9005052)
- Roles
- Complaint file establishment
- First device listed
- March 3, 2025
- Registered through
- 2027
- Brand names listed
- Neodent Titanium Block for Medentika Holder, Straumann InLab Validated Workflow, Straumann Pre-Milled Abutment Blank for Medentika Holder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment | accessdata.fda.gov |
| Dental Abutment Design Software For Dental Laboratory | PNP | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 19, 2025 | K243478 | Straumann InLab Validated Workflow | NHA | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 12, 2026 | 99707 | Class II | Ongoing | GM Helix Implant, REF: | There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. | accessdata.fda.gov |
| July 16, 2026 | 99441 | Class II | Ongoing | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article ); implant, endosseous, root-form | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest. | accessdata.fda.gov |
| July 13, 2026 | 99407 | Class II | Ongoing | GM Helix Implant, Endosseous Dental Implant Article No. | There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume | accessdata.fda.gov |
| March 27, 2026 | 98681 | Class II | Ongoing | Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article. Endosseous Dental Implant Abutments | Includes an incorrect screw seat interface. | accessdata.fda.gov |
| March 17, 2026 | 98565 | Class II | Ongoing | Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: | A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396 | accessdata.fda.gov |
| January 6, 2026 | 98265 | Class III | Ongoing | WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM | The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. | accessdata.fda.gov |
| October 17, 2025 | 97753 | Class II | Ongoing | Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10 | The possibility for this product that is intended for demonstration purposes only to be placed in patients. | accessdata.fda.gov |
| May 1, 2025 | 96806 | Class II | Ongoing | GM Helix Acqua Implant, Article Number: | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | accessdata.fda.gov |
| April 17, 2025 | 96726 | Class II | Ongoing | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | Incorrect blister labelling. | accessdata.fda.gov |
| April 14, 2025 | 96798 | Class II | Ongoing | Plus Initial Drill, Article Number: | The referred batch was produced without the laser engraving of 7 mm. | accessdata.fda.gov |
| March 8, 2025 | 96516 | Class II | Ongoing | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: | The devices are missing the laser marked depth markings. | accessdata.fda.gov |
| November 30, 2021 | 89321 | Class II | Terminated | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant | accessdata.fda.gov |
| June 25, 2021 | 88427 | Class II | Ongoing | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005 | Product label intended for the European community was distributed to the USA market via their US distribution organization | accessdata.fda.gov |
| May 27, 2021 | 88282 | Class II | Terminated | Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number:. dental surgical instrument. | Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury | accessdata.fda.gov |
| October 2, 2018 | 81456 | Class II | Terminated | Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape fo | Laser engraved label does not match with the item in the package | accessdata.fda.gov |
| March 23, 2018 | 79738 | Class II | Terminated | Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | accessdata.fda.gov |
| March 13, 2017 | 76843 | Class II | Terminated | NEODENT CM Intraoral Scanbody, Article Number: | During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned. | accessdata.fda.gov |
| November 23, 2016 | 75983 | Class II | Terminated | Straumann Drill 1, short, 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental impl | Drills cannot be inserted into handpiece due to tolerance specification not met | accessdata.fda.gov |
| July 14, 2016 | 74799 | Class II | Terminated | Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration | accessdata.fda.gov |
| October 27, 2014 | 69767 | Class II | Terminated | Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set. | Drill set may contain incorrect drill. | accessdata.fda.gov |
| September 24, 2014 | 69454 | Class II | Terminated | Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosth | Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) | accessdata.fda.gov |
| September 19, 2014 | 69379 | Class II | Terminated | Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for pros | Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) | accessdata.fda.gov |
| August 11, 2014 | 69835 | Class II | Terminated | Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic resto | Product not approved for use in the US | accessdata.fda.gov |
| July 11, 2012 | 62575 | Class II | Terminated | Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide | Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2 | accessdata.fda.gov |
| March 12, 2012 | 61440 | Not yet classified | Terminated | Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations | Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN | accessdata.fda.gov |
| August 4, 2011 | 59797 | Not yet classified | Terminated | Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill. Imaging processing System | Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed. | accessdata.fda.gov |
| September 30, 2010 | 56994 | Not yet classified | Terminated | Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10 | Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve. | accessdata.fda.gov |
| June 15, 2010 | 56049 | Not yet classified | Terminated | Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : Kit Y4021. Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants. | The label on the tubular packaging for the Straumann Impression set f. WN solid abutment has the incorrect description of RN solid abutment instead of a WN. | accessdata.fda.gov |
| June 4, 2009 | 52231 | Not yet classified | Terminated | Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use as a drilling guide to prepare a site for placement of a dental implant into the dental implant site. | Incorrect Inner diameter of the T-sleeve | accessdata.fda.gov |
| May 28, 2008 | 48610 | Not yet classified | Terminated | Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot dril | Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device. | accessdata.fda.gov |
| January 10, 2008 | 46358 | Not yet classified | Terminated | Straumann NC Closure Screw, Titanium, Precision attachment, Article Number:.04, Straumann, Andover, MA 01810 | Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection. | accessdata.fda.gov |
| March 30, 2006 | 35220 | Not yet classified | Terminated | Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: | The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top | accessdata.fda.gov |
| January 30, 2006 | 34614 | Not yet classified | Terminated | Thermoplastic templates, single tooth Catalog Number: | Pilot drills may not fully extend through drill guide in template products | accessdata.fda.gov |
| June 6, 2005 | 32354 | Not yet classified | Terminated | RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: | Basal screw is too short to adequately hold the dental abutment in the implant | accessdata.fda.gov |
| November 11, 2004 | 30482 | Not yet classified | Terminated | Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: | Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN) | accessdata.fda.gov |
| May 21, 2004 | 29271 | Not yet classified | Terminated | Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. | Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN) | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Dental Abutment Design Software For Dental Laboratory
Updated September 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.