Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nobelpharma USA, Inc. — Predicate Candidate Screening
64 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
451 days90th percentile
64clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIAT | Nobelpharma USA, Inc. | 1999-06-28 | 221 | 0 |
| K962403 | NOBLEPHARMA WIDE ACCESSORIES | Nobelpharma USA, Inc. | 1996-09-06 | 77 | 0 |
| K955713 | NOBELPHARMA BONE ANCHORED HEARING AID | Nobelpharma USA, Inc. | 1996-08-09 | 235 | 0 |
| K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE | Nobelpharma USA, Inc. | 1996-07-22 | 49 | 0 |
| K961736 | 17 ANGULATED ABUTMENT | Nobelpharma USA, Inc. | 1996-07-18 | 76 | 0 |
| K961737 | CERA ONE ABUTMENT SYSTEM | Nobelpharma USA, Inc. | 1996-07-10 | 68 | 0 |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | Nobelpharma USA, Inc. | 1996-07-10 | 68 | 0 |
| K960639 | ABUTMENT SELECTION KIT | Nobelpharma USA, Inc. | 1996-05-14 | 90 | 0 |
| K955697 | ABUTMENT RETRIEVAL KIT | Nobelpharma USA, Inc. | 1996-01-30 | 47 | 1 |
| K955372 | BALL ATTACHMENT SYSTEM | Nobelpharma USA, Inc. | 1996-01-23 | 62 | 0 |
| K953435 | BRANEMARK RADIOGRAPHIC DEPTH GUAGE | Nobelpharma USA, Inc. | 1995-10-03 | 74 | 0 |
| K953774 | BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY | Nobelpharma USA, Inc. | 1995-09-27 | 44 | 0 |
| K953775 | BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) | Nobelpharma USA, Inc. | 1995-09-21 | 38 | 0 |
| K952685 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS | Nobelpharma USA, Inc. | 1995-09-18 | 98 | 0 |
| K952886 | BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM | Nobelpharma USA, Inc. | 1995-09-18 | 87 | 0 |
| K952676 | BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM | Nobelpharma USA, Inc. | 1995-08-11 | 60 | 0 |
| K933148 | SURGICAL DRAPE KIT | Nobelpharma USA, Inc. | 1995-06-26 | 727 | 0 |
| K952448 | 3.3MM ACCESSORIES | Nobelpharma USA, Inc. | 1995-06-20 | 26 | 0 |
| K945398 | BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE | Nobelpharma USA, Inc. | 1995-04-13 | 161 | 0 |
| K944683 | BRANEMARK SYSTEM 3.3MM FIXTURE | Nobelpharma USA, Inc. | 1995-03-08 | 167 | 0 |
| K944964 | BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM | Nobelpharma USA, Inc. | 1995-02-28 | 144 | 0 |
| K944962 | BRANEMARK SYSTEM 17 ANGULATED ABUTMENT | Nobelpharma USA, Inc. | 1995-02-27 | 143 | 0 |
| K944963 | BRANEMARK SYSTEM SMILINE II | Nobelpharma USA, Inc. | 1995-02-17 | 133 | 0 |
| K945154 | BA-CPAS | Nobelpharma USA, Inc. | 1995-01-13 | 84 | 0 |
| K944702 | PROCERA ALL-CERAMIC PORCELAIN | Nobelpharma USA, Inc. | 1994-12-02 | 71 | 0 |
| K931785 | BRANEMARK SYSTEM DRILL CONTROLLER | Nobelpharma USA, Inc. | 1994-08-09 | 487 | 0 |
| K934825 | BRANEMARK SYSTEM | Nobelpharma USA, Inc. | 1994-08-08 | 304 | 0 |
| K934827 | BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM | Nobelpharma USA, Inc. | 1994-08-08 | 304 | 0 |
| K934826 | BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104 | Nobelpharma USA, Inc. | 1994-08-08 | 304 | 0 |
| K925766 | BRANEMARK SYSTEM TEMPORARY SOLUTIONS | Nobelpharma USA, Inc. | 1994-08-02 | 624 | 0 |
| K925483 | BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276 | Nobelpharma USA, Inc. | 1994-05-02 | 549 | 0 |
| K933149 | INSTRUMENT DETERGENT CONCENTRATE | Nobelpharma USA, Inc. | 1994-02-16 | 232 | 0 |
| K925776 | BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND | Nobelpharma USA, Inc. | 1994-02-10 | 451 | 0 |
| K925767 | BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP. | Nobelpharma USA, Inc. | 1993-10-20 | 338 | 0 |
| K933150 | NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE | Nobelpharma USA, Inc. | 1993-10-20 | 113 | 0 |
| K925762 | BRANEMARK SYSTEM SELF-TAPPING FIXTURE | Nobelpharma USA, Inc. | 1993-10-12 | 333 | 0 |
| K925487 | NOBLEPHARMA BRANEMARK SYSTEM GOLD CYLINDERS | Nobelpharma USA, Inc. | 1993-10-12 | 347 | 0 |
| K925764 | BRANEMARK SYSTEM 4.00 MM FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | 326 | 0 |
| K925760 | BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | 326 | 0 |
| K926501 | BRANEMARK SYSTEM(R) - 5.5MM FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | 280 | 0 |
| K925765 | BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | 326 | 0 |
| K925761 | BRANEMARK SYSTEM 5.0 X 14MM FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | 326 | 0 |
| K925772 | BRANEMARK SYSTEM GUIDE PINS | Nobelpharma USA, Inc. | 1993-09-16 | 304 | 0 |
| K925774 | BRANEMARK SYSTEM HAND INSTRUMENT | Nobelpharma USA, Inc. | 1993-09-16 | 304 | 0 |
| K925768 | BRANEMARK SYSTEM SCREW TAP | Nobelpharma USA, Inc. | 1993-09-16 | 304 | 0 |
| K925770 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS | Nobelpharma USA, Inc. | 1993-09-16 | 304 | 0 |
| K925775 | BRANEMARK SYSTEM MACHINE INST. ACC. TO DRILLING EQ | Nobelpharma USA, Inc. | 1993-09-16 | 304 | 0 |
| K920452 | THE BRANEMARK SYSTEM BALL ATTACHMENT ABUTMENT SYST | Nobelpharma USA, Inc. | 1993-09-13 | 587 | 0 |
| K922805 | NOBELPHARMA TORQUE CONTROLLER | Nobelpharma USA, Inc. | 1993-07-22 | 407 | 0 |
| K925779 | BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS | Nobelpharma USA, Inc. | 1993-04-20 | 155 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda