The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Temp-bond Ne 2.
| Device ID | K003658 |
| 510k Number | K003658 |
| Device Name: | TEMP-BOND NE 2 |
| Classification | Cement, Dental |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-28 |
| Decision Date | 2001-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841396112888 | K003658 | 000 |