Data / Medical devices / United States / Nobel Biocare Usa, LLC

Nobel Biocare Usa, LLC: FDA-registered device maker in Yorba Linda, CA, United States, 1 510(k) clearance

Name: Nobel Biocare Usa, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nobel Biocare Usa, LLC is registered with the FDA (registration 2027971) in Yorba Linda, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 6, 2026. 14 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2027971
FEI number: 1000125598
Address: 22715 Savi Ranch Parkway, Yorba Linda, CA, United States, 92887
Owner or operator: Nobel Biocare Services AG (8030879)
Roles: Contract manufacturer, Manufacturer
First device listed: July 8, 2003
Registered through: 2027
Brand names listed: 1st Generation Surgical Templates, NobelGuide, 2nd Generation Surgical Templates, NobelGuide, Abutment Release Pin, Abutment Replica Multi-unit, Abutment Replica Snappy, Abutment Retrieval Tools/Instruments Titanium, Abutment Retrieval Tools/Instruments Zirconia, Abutment Screw and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Contract manufacturer	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Contract manufacturer	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
August 6, 2026	K253999	Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw	NHA	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 17, 2021	89465	Class II	Terminated	NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R	Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.	accessdata.fda.gov
August 28, 2019	85236	Class II	Terminated	NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegratio	The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).	accessdata.fda.gov
August 9, 2019	85159	Class II	Terminated	Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper	Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.	accessdata.fda.gov
July 19, 2019	85331	Class II	Terminated	NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619	The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.	accessdata.fda.gov
May 28, 2019	85530	Class II	Terminated	Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements t	Packaged dental implant healing abutments were found to contain the wrong size device.	accessdata.fda.gov
March 14, 2019	84450	Class II	Terminated	Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants	Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.	accessdata.fda.gov
March 16, 2018	80393	Class II	Terminated	Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Mul	The product label has missing information, such as the lot number and expiration date, as well as other information.	accessdata.fda.gov
July 20, 2016	74782	Class II	Terminated	Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection	Incorrect drill protocol in the Instructions for Use (IFU)	accessdata.fda.gov
June 22, 2016	74486	Class II	Terminated	Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide supp	Incorrect top label on an implant package.	accessdata.fda.gov
June 22, 2015	71552	Class II	Terminated	Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck	One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.	accessdata.fda.gov
March 9, 2015	70821	Class II	Terminated	Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide suppor	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.	accessdata.fda.gov
October 24, 2013	66664	Class II	Terminated	Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I,	The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.	accessdata.fda.gov
November 2, 2007	48702	Not yet classified	Terminated	NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.	This recall was initiated after it was discovered that the NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. The affected lot has a cap label identifying the implant as "4.3x8". Since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the	accessdata.fda.gov
January 27, 2003	25471	Not yet classified	Terminated	Nobel Biocare Replace Select Radiographic Template, part number 30159.	Misprinted radiographic template plates. Misprinted labeling.	accessdata.fda.gov

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Updated August 6, 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.