The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for Unifast Lc.
| Device ID | K890829 |
| 510k Number | K890829 |
| Device Name: | UNIFAST LC |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale, AZ 85260 |
| Contact | Donald A Mckenzie |
| Correspondent | Donald A Mckenzie G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale, AZ 85260 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-21 |
| Decision Date | 1989-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6583382032 | K890829 | 000 |
| 20386040006665 | K890829 | 000 |
| 20386040006658 | K890829 | 000 |
| 20386040006641 | K890829 | 000 |
| 20386040006634 | K890829 | 000 |
| 20386040006627 | K890829 | 000 |
| 10386040006613 | K890829 | 000 |
| 10386040006606 | K890829 | 000 |
| 10386040006590 | K890829 | 000 |
| 10386040006583 | K890829 | 000 |
| 10386040006576 | K890829 | 000 |
| 10386040006569 | K890829 | 000 |
| 10386040001137 | K890829 | 000 |
| 20386040006672 | K890829 | 000 |
| D0470003682 | K890829 | 000 |
| D6583381222 | K890829 | 000 |
| D6583381132 | K890829 | 000 |
| D6583381122 | K890829 | 000 |
| D6583381032 | K890829 | 000 |
| D6583381022 | K890829 | 000 |
| D6583380221 | K890829 | 000 |
| D6583380211 | K890829 | 000 |
| D6583380131 | K890829 | 000 |
| D6583380121 | K890829 | 000 |
| D6583380061 | K890829 | 000 |
| D6583380031 | K890829 | 000 |
| D6583380021 | K890829 | 000 |
| 24548161283271 | K890829 | 000 |