The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Permlastic 3.
| Device ID | K003650 |
| 510k Number | K003650 |
| Device Name: | PERMLASTIC 3 |
| Classification | Material, Impression |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-27 |
| Decision Date | 2001-02-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841396118767 | K003650 | 000 |
| 00841396118630 | K003650 | 000 |
| 00841396118647 | K003650 | 000 |
| 00841396118654 | K003650 | 000 |
| 00841396118661 | K003650 | 000 |
| 00841396118678 | K003650 | 000 |
| 00841396118685 | K003650 | 000 |
| 00841396118708 | K003650 | 000 |
| 00841396118715 | K003650 | 000 |
| 00841396118722 | K003650 | 000 |
| 10841396118743 | K003650 | 000 |
| 10841396118750 | K003650 | 000 |
| 00195062037979 | K003650 | 000 |