Not currently registered with FDA under this name
Nobelpharma USA, Inc.
Westmont, IL, United States. Named as applicant on 59 dental 510(k) clearances between 1990 and 1996. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 591990–1996
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Nobelpharma USA, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Sep 1996 | K962403 | NOBLEPHARMA WIDE ACCESSORIES | DZE Root-Form Endosseous Implant |
| 22 Jul 1996 | K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE | DZE Root-Form Endosseous Implant |
| 18 Jul 1996 | K961736 | 17 ANGULATED ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 10 Jul 1996 | K961737 | CERA ONE ABUTMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Jul 1996 | K961728 | MIRUSCONE ABUTMENT SYSTEM | NHA Endosseous Dental Implant Abutment |
| 14 May 1996 | K960639 | ABUTMENT SELECTION KIT | DZE Root-Form Endosseous Implant |
| 30 Jan 1996 | K955697 | ABUTMENT RETRIEVAL KIT | DZE Root-Form Endosseous Implant |
| 23 Jan 1996 | K955372 | BALL ATTACHMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 3 Oct 1995 | K953435 | BRANEMARK RADIOGRAPHIC DEPTH GUAGE | DZE Root-Form Endosseous Implant |
| 27 Sep 1995 | K953774 | BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY | DZE Root-Form Endosseous Implant |
| 21 Sep 1995 | K953775 | BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) | DZE Root-Form Endosseous Implant |
| 18 Sep 1995 | K952886 | BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM | DZE Root-Form Endosseous Implant |
| 18 Sep 1995 | K952685 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS | DZE Root-Form Endosseous Implant |
| 11 Aug 1995 | K952676 | BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 20 Jun 1995 | K952448 | 3.3MM ACCESSORIES | DZE Root-Form Endosseous Implant |
| 13 Apr 1995 | K945398 | BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE | DZE Root-Form Endosseous Implant |
| 8 Mar 1995 | K944683 | BRANEMARK SYSTEM 3.3MM FIXTURE | DZE Root-Form Endosseous Implant |
| 28 Feb 1995 | K944964 | BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 27 Feb 1995 | K944962 | BRANEMARK SYSTEM 17 ANGULATED ABUTMENT | DZE Root-Form Endosseous Implant |
| 17 Feb 1995 | K944963 | BRANEMARK SYSTEM SMILINE II | DZE Root-Form Endosseous Implant |
| 2 Dec 1994 | K944702 | PROCERA ALL-CERAMIC PORCELAIN | EIH Porcelain Powder |
| 9 Aug 1994 | K931785 | BRANEMARK SYSTEM DRILL CONTROLLER | DZE Root-Form Endosseous Implant |
| 8 Aug 1994 | K934827 | BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM | DZE Root-Form Endosseous Implant |
| 8 Aug 1994 | K934826 | BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104 | DZE Root-Form Endosseous Implant |
| 8 Aug 1994 | K934825 | BRANEMARK SYSTEM | DZE Root-Form Endosseous Implant |
| 2 Aug 1994 | K925766 | BRANEMARK SYSTEM TEMPORARY SOLUTIONS | DZE Root-Form Endosseous Implant |
| 2 May 1994 | K925483 | BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276 | DZE Root-Form Endosseous Implant |
| 10 Feb 1994 | K925776 | BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND | DZE Root-Form Endosseous Implant |
| 20 Oct 1993 | K933150 | NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE | DZE Root-Form Endosseous Implant |
| 20 Oct 1993 | K925767 | BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP. | DZE Root-Form Endosseous Implant |
| 12 Oct 1993 | K925762 | BRANEMARK SYSTEM SELF-TAPPING FIXTURE | DZE Root-Form Endosseous Implant |
| 12 Oct 1993 | K925487 | NOBLEPHARMA BRANEMARK SYSTEM GOLD CYLINDERS | DZE Root-Form Endosseous Implant |
| 5 Oct 1993 | K926501 | BRANEMARK SYSTEM(R) - 5.5MM FIXTURE | DZE Root-Form Endosseous Implant |
| 5 Oct 1993 | K925765 | BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE | DZE Root-Form Endosseous Implant |
| 5 Oct 1993 | K925764 | BRANEMARK SYSTEM 4.00 MM FIXTURE | DZE Root-Form Endosseous Implant |
| 5 Oct 1993 | K925761 | BRANEMARK SYSTEM 5.0 X 14MM FIXTURE | DZE Root-Form Endosseous Implant |
| 5 Oct 1993 | K925760 | BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE | DZE Root-Form Endosseous Implant |
| 16 Sep 1993 | K925775 | BRANEMARK SYSTEM MACHINE INST. ACC. TO DRILLING EQ | DZE Root-Form Endosseous Implant |
| 16 Sep 1993 | K925774 | BRANEMARK SYSTEM HAND INSTRUMENT | DZE Root-Form Endosseous Implant |
| 16 Sep 1993 | K925772 | BRANEMARK SYSTEM GUIDE PINS | DZE Root-Form Endosseous Implant |
| 16 Sep 1993 | K925770 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS | DZE Root-Form Endosseous Implant |
| 16 Sep 1993 | K925768 | BRANEMARK SYSTEM SCREW TAP | DZE Root-Form Endosseous Implant |
| 13 Sep 1993 | K920452 | THE BRANEMARK SYSTEM BALL ATTACHMENT ABUTMENT SYST | DZE Root-Form Endosseous Implant |
| 22 Jul 1993 | K922805 | NOBELPHARMA TORQUE CONTROLLER | DZE Root-Form Endosseous Implant |
| 20 Apr 1993 | K925779 | BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 14 Apr 1993 | K925780 | BRANEMARK SYSTEM HEALING CAPS | DZE Root-Form Endosseous Implant |
| 14 Apr 1993 | K925778 | BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES | DZE Root-Form Endosseous Implant |
| 14 Apr 1993 | K925777 | BRANEMARK SYSTEM ESTHETICONE ABUTMENT COMPLETE | DZE Root-Form Endosseous Implant |
| 14 Apr 1993 | K925773 | BRANEMARK SYSTEM GOLD CYLINDERS AND SCREWS | DZE Root-Form Endosseous Implant |
| 14 Apr 1993 | K925771 | BRANEMARK SYSTEM TITANIUM COVER SCREWS | DZE Root-Form Endosseous Implant |
| 14 Apr 1993 | K925769 | BRANEMARK SYSTEM ABUTMENTS COMPLETE | NHA Endosseous Dental Implant Abutment |
| 27 Aug 1992 | K905434 | ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102 | DZE Root-Form Endosseous Implant |
| 3 Feb 1992 | K915276 | DENTURE PLASTIC TEETH,76 ELM | ELM Teeth Plastic Denture |
| 19 Dec 1991 | K911960 | BRANEMARK SYSTEM-3.0MM FIXTURE | DZE Root-Form Endosseous Implant |
| 16 Aug 1991 | K910611 | NOBELPHARMA CERAONE ABUTMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 25 Jul 1991 | K911961 | BRANEMARK SYSTEM-5.0MM FIXTURE | DZE Root-Form Endosseous Implant |
| 24 Jun 1991 | K901552 | (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE | EJH Base Metal Alloy |
| 4 Mar 1991 | K905436 | NOBELPHARMA DRILLING EQUIPMENT DEC 500 | DZE Root-Form Endosseous Implant |
| 9 Nov 1990 | K903907 | PROCERAM PORCELAIN | ELL Porcelain Teeth |
Some of these clearances are listed with FDA today by another company: Nobel Biocare Services AG (4).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.