Data / Medical devices / United States / Keystone Dental Inc.
Keystone Dental Inc.: FDA-registered device maker in Irvine, CA, United States, 46 510(k) clearances
Keystone Dental Inc. is registered with the FDA (registration 3011936113) in Irvine, CA, United States. It lists 12 device types. The FDA files 46 510(k) clearances under its listings, the newest dated July 9, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011936113
- Address
- 13645 Alton Pkwy Ste A, Irvine, CA, United States, 92618
- Owner or operator
- Keystone Dental Inc. (9096980)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- January 23, 2007
- Registered through
- 2026
- Brand names listed
- Accell Connexus, Arcitexture Surface Technology, Bone Profiler w/Guide Pin for External Hex Implants, Bone Profiler with Centering Pin for PrimaConnex Implants, Calforma Calcium Sulfate Bone Graft, Calmatrix Calcium Sulfate Bone Graf, Co Axis, Co-Axis Implant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Human Source | NUN | 2 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Dental Implant Surgical Tray | OFY | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer | accessdata.fda.gov |
| Teeth, Porcelain | ELL | 2 | 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 |
|---|---|---|---|---|---|---|
| July 9, 2024 | K240966 | Prima Plus Conical Implant System | DZE | Substantially Equivalent | Keystone Dental, Inc. | accessdata.fda.gov |
| May 25, 2023 | K223814 | Genesis ACTIVE Implant System | DZE | Substantially Equivalent | Keystone Dental, Inc. | accessdata.fda.gov |
| August 10, 2022 | K221381 | KDG Abutments | NHA | Substantially Equivalent | Keystone Dental, Inc. | accessdata.fda.gov |
| October 28, 2010 | K101545 | GENESIS IMPLANT SYSTEM | DZE | Substantially Equivalent | Keystone Dental | accessdata.fda.gov |
| October 14, 2010 | K093562 | ENDOSSEOUS DENTAL IMPLANT | DZE | Substantially Equivalent | Southern Implants, Inc. | accessdata.fda.gov |
| December 22, 2008 | K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Southern Implants, Inc. | accessdata.fda.gov |
| November 16, 2007 | K073032 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS | NHA | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| November 16, 2007 | K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Southern Implants, Inc. | accessdata.fda.gov |
| November 9, 2007 | K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM | NHA | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| October 23, 2007 | K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| October 5, 2007 | K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS | NHA | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| June 21, 2007 | K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Southern Implants, Inc. | accessdata.fda.gov |
| May 24, 2007 | K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Southern Implants, Inc. | accessdata.fda.gov |
| November 1, 2006 | K062876 | PRIMACONNEX CERAMIC ABUTMENTS | NHA | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| June 20, 2006 | K061169 | ENDOSSEOUS DENTAL IMPLANT | DZE | Substantially Equivalent | Northern Implants, LLC | accessdata.fda.gov |
| May 22, 2006 | K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. | ELL | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| March 29, 2006 | K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | NUN | Substantially Equivalent | Isotis NV | accessdata.fda.gov |
| March 27, 2006 | K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | NUN | Substantially Equivalent | Isotis NV | accessdata.fda.gov |
| January 23, 2006 | K053643 | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 | NHA | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| December 8, 2005 | K052490 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Northern Implants, LLC | accessdata.fda.gov |
| September 9, 2005 | K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| July 29, 2005 | K043573 | DYNAGRAFT II DENTAL | NUN | Substantially Equivalent | Isotis Orthobiologics, Inc. | accessdata.fda.gov |
| April 15, 2005 | K050506 | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| February 14, 2005 | K042730 | CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G | LYC | Substantially Equivalent | Lifecorebiomedical | accessdata.fda.gov |
| July 19, 2004 | K041324 | CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER | LYC | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| April 27, 2004 | K033171 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING | DZE | Substantially Equivalent | Northern Implants, LLC | accessdata.fda.gov |
| September 17, 2003 | K032495 | THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| May 10, 2002 | K020617 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM | DZE | Substantially Equivalent | Nsi | accessdata.fda.gov |
| September 19, 2001 | K003620 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM | DZE | Substantially Equivalent | Nsi | accessdata.fda.gov |
| May 16, 2001 | K002037 | LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| January 12, 2001 | K003226 | THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| March 8, 2000 | K993894 | LIFECORE SINGLE TOOTH ABUTMENT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| February 29, 2000 | K994205 | MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| July 14, 1999 | K991114 | REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| May 27, 1997 | K970776 | LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| March 28, 1996 | K960288 | HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| February 23, 1996 | K954512 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| January 11, 1996 | K954865 | RESTORE HA DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| January 11, 1996 | K954819 | RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| August 30, 1995 | K950624 | HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| March 31, 1995 | K951111 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM) | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| February 28, 1995 | K944069 | RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| February 2, 1995 | K944068 | RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM) | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| July 22, 1994 | K941554 | SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| July 12, 1994 | K931468 | RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
| February 3, 1994 | K914137 | HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | Lifecore Biomedical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Bone Grafting Material, Synthetic
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Teeth, Porcelain
- All makers of Drill, Dental, Intraoral
Updated July 9, 2024. 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.