Nobel Biocare Uas, Inc.
Yorba Linda, CA, US
Nobel Biocare Uas, Inc. appears in FDA device records in Yorba Linda, CA. FDA records list 31 510(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
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Nobel Biocare Uas, Inc. between 1997 and 2005. The busiest year on record is 2004, with 7. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 3 |
| 1998 | 5 |
| 1999 | 3 |
| 2000 | 5 |
| 2002 | 4 |
| 2003 | 3 |
| 2004 | 7 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050444 | NOBELREPLACE ADAPTER, MODEL 32412 | NHA | Substantially Equivalent | |
| K042658 | PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 | NHA | Substantially Equivalent | |
| K041661 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS | DZE | Substantially Equivalent | |
| K041876 | NOBELDIRECT OD IMPLANT | DZE | Substantially Equivalent | |
| K041312 | NOBELRONDO DENTAL CERAMIC-ALUMINA | EIH | Substantially Equivalent | |
| K041275 | PROCERA ABUTMENT OCTAGON | NHA | Substantially Equivalent | |
| K040573 | NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236 | NHA | Substantially Equivalent | |
| K033724 | NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 | NHA | Substantially Equivalent | |
| K031345 | NOBEL DIRECT, MODELS 30937, 30938 | DZE | Substantially Equivalent | |
| K030257 | NOBEL PERFECT IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K023952 | REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE | DZE | Substantially Equivalent | |
| K022424 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 | DZE | Substantially Equivalent | |
| K023113 | REPLACE TIUNITE ENDOSSEOUS IMPLANT | DZE | Substantially Equivalent | |
| K021584 | REPLACE SCALLOPED MARGIN IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K020646 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 | DZE | Substantially Equivalent | |
| K002475 | REPLACE TPS COATED IMPLANTS | DZE | Substantially Equivalent | |
| K000643 | INPLANT ORTHODONTIC ANCHOR SYSTEM | DZE | Substantially Equivalent | |
| K000018 | BRANEMARK NOVUM | DZE | Substantially Equivalent | |
| K992937 | DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K993595 | NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT) | DZE | Substantially Equivalent | |
| K992538 | AMORPHOUS DIAMOND COATED SCREW | DZE | Substantially Equivalent | |
| K990846 | AMORPHOUS DIAMOND COATED DRILL | DZI | Substantially Equivalent | |
| K984287 | PROVISIONAL DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K983453 | PROCERA ALLCERAM FUSING MATERIAL | EIH | Substantially Equivalent | |
| K974123 | BRANEMARK SYSTEM DEC 600 DRILLING UNIT | DZE | Substantially Equivalent | |
| K980460 | ONPLANT ORTHODONTIC SYSTEM | DZE | Substantially Equivalent | |
| K974828 | BRANEMARK SYSTEM(R) EBON(TM) FIXTURE | DZE | Substantially Equivalent | |
| K974150 | PROCERA PREPARABLE ABUTMENT SYSTEM | NHA | Substantially Equivalent | |
| K970499 | BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM | DZE | Substantially Equivalent | |
| K972475 | AURADAPT AUBTMENT SYSTEM | NHA | Substantially Equivalent | |
| K971706 | TIADAPT ABUTMENT SYSTEM | NHA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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