Nobelpharma USA, Inc.
Chicago, IL, US
Nobelpharma USA, Inc. appears in FDA device records in Chicago, IL. FDA records list 64 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 64
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 64FDA records hold 64 510(k) clearances for Nobelpharma USA, Inc. between 1990 and 1999. The busiest year on record is 1993, with 23. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 5 |
| 1992 | 2 |
| 1993 | 23 |
| 1994 | 9 |
| 1995 | 14 |
| 1996 | 9 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | MAH | Substantially Equivalent | |
| K962403 | NOBLEPHARMA WIDE ACCESSORIES | DZE | Substantially Equivalent | |
| K955713 | NOBELPHARMA BONE ANCHORED HEARING AID | LXB | Substantially Equivalent | |
| K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE | DZE | Substantially Equivalent | |
| K961736 | 17 ANGULATED ABUTMENT | NHA | Substantially Equivalent | |
| K961737 | CERA ONE ABUTMENT SYSTEM | DZE | Substantially Equivalent | |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | NHA | Substantially Equivalent | |
| K960639 | ABUTMENT SELECTION KIT | DZE | Substantially Equivalent | |
| K955697 | ABUTMENT RETRIEVAL KIT | DZE | Substantially Equivalent | |
| K955372 | BALL ATTACHMENT SYSTEM | DZE | Substantially Equivalent | |
| K953435 | BRANEMARK RADIOGRAPHIC DEPTH GUAGE | DZE | Substantially Equivalent | |
| K953774 | BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY | DZE | Substantially Equivalent | |
| K953775 | BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) | DZE | Substantially Equivalent | |
| K952886 | BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM | DZE | Substantially Equivalent | |
| K952685 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS | DZE | Substantially Equivalent | |
| K952676 | BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM | DZE | Substantially Equivalent | |
| K933148 | SURGICAL DRAPE KIT | KKX | Substantially Equivalent | |
| K952448 | 3.3MM ACCESSORIES | DZE | Substantially Equivalent | |
| K945398 | BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE | DZE | Substantially Equivalent | |
| K944683 | BRANEMARK SYSTEM 3.3MM FIXTURE | DZE | Substantially Equivalent | |
| K944964 | BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM | DZE | Substantially Equivalent | |
| K944962 | BRANEMARK SYSTEM 17 ANGULATED ABUTMENT | DZE | Substantially Equivalent | |
| K944963 | BRANEMARK SYSTEM SMILINE II | DZE | Substantially Equivalent | |
| K945154 | BA-CPAS | FZE | Substantially Equivalent | |
| K944702 | PROCERA ALL-CERAMIC PORCELAIN | EIH | Substantially Equivalent | |
| K931785 | BRANEMARK SYSTEM DRILL CONTROLLER | DZE | Substantially Equivalent | |
| K934827 | BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM | DZE | Substantially Equivalent | |
| K934826 | BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104 | DZE | Substantially Equivalent | |
| K934825 | BRANEMARK SYSTEM | DZE | Substantially Equivalent | |
| K925766 | BRANEMARK SYSTEM TEMPORARY SOLUTIONS | DZE | Substantially Equivalent | |
| K925483 | BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276 | DZE | Substantially Equivalent | |
| K933149 | INSTRUMENT DETERGENT CONCENTRATE | FLG | Substantially Equivalent | |
| K925776 | BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND | DZE | Substantially Equivalent | |
| K933150 | NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE | DZE | Substantially Equivalent | |
| K925767 | BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP. | DZE | Substantially Equivalent | |
| K925762 | BRANEMARK SYSTEM SELF-TAPPING FIXTURE | DZE | Substantially Equivalent | |
| K925487 | NOBLEPHARMA BRANEMARK SYSTEM GOLD CYLINDERS | DZE | Substantially Equivalent | |
| K926501 | BRANEMARK SYSTEM(R) - 5.5MM FIXTURE | DZE | Substantially Equivalent | |
| K925765 | BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE | DZE | Substantially Equivalent | |
| K925764 | BRANEMARK SYSTEM 4.00 MM FIXTURE | DZE | Substantially Equivalent | |
| K925761 | BRANEMARK SYSTEM 5.0 X 14MM FIXTURE | DZE | Substantially Equivalent | |
| K925760 | BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE | DZE | Substantially Equivalent | |
| K925775 | BRANEMARK SYSTEM MACHINE INST. ACC. TO DRILLING EQ | DZE | Substantially Equivalent | |
| K925774 | BRANEMARK SYSTEM HAND INSTRUMENT | DZE | Substantially Equivalent | |
| K925772 | BRANEMARK SYSTEM GUIDE PINS | DZE | Substantially Equivalent | |
| K925770 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS | DZE | Substantially Equivalent | |
| K925768 | BRANEMARK SYSTEM SCREW TAP | DZE | Substantially Equivalent | |
| K920452 | THE BRANEMARK SYSTEM BALL ATTACHMENT ABUTMENT SYST | DZE | Substantially Equivalent | |
| K922805 | NOBELPHARMA TORQUE CONTROLLER | DZE | Substantially Equivalent | |
| K925779 | BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS | NHA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- EJHAlloy, Metal, Base
- FLGCleaner, Ultrasonic, Medical Instrument
- ELMDenture, Plastic, Teeth
- KKXDrape, Surgical, Antimicrobial
- LXBHearing Aid, Bone Conduction
- MAHHearing Aid, Bone Conduction, Implanted
- DZEImplant, Endosseous, Root-Form
- EIHPowder, Porcelain
- FZEProsthesis, Nose, Internal
- ELLTeeth, Porcelain
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain