The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Revotek Lc.
| Device ID | K012542 |
| 510k Number | K012542 |
| Device Name: | REVOTEK LC |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz |
| Correspondent | Terry L Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-07 |
| Decision Date | 2001-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470018421 | K012542 | 000 |
| 14548161062084 | K012542 | 000 |