SPECTRAMAT
Activator, Ultraviolet, For Polymerization
IVOCLAR NORTH AMERICA, INC.
The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Spectramat.
Pre-market Notification Details
| Device ID | K910068 |
| 510k Number | K910068 |
| Device Name: | SPECTRAMAT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Gary Severance |
| Correspondent | Gary Severance IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1991-03-15 |
Trademark Results [SPECTRAMAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPECTRAMAT 74480948 not registered Dead/Abandoned |
IVOCLAR AG 1994-01-21 |
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