The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Optiglaze Color.
| Device ID | K133836 |
| 510k Number | K133836 |
| Device Name: | OPTIGLAZE COLOR |
| Classification | Coating, Filling Material, Resin |
| Applicant | GC AMERICA INC. 3737 W. 127TH STREET Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA INC. 3737 W. 127TH STREET Alsip, IL 60803 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-18 |
| Decision Date | 2014-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14548161292122 | K133836 | 000 |
| 14548161282765 | K133836 | 000 |
| 14548161283298 | K133836 | 000 |
| 14548161283304 | K133836 | 000 |
| 14548161283311 | K133836 | 000 |
| 14548161283328 | K133836 | 000 |
| 14548161283335 | K133836 | 000 |
| 14548161283342 | K133836 | 000 |
| 14548161283359 | K133836 | 000 |
| 14548161292030 | K133836 | 000 |
| 14548161292047 | K133836 | 000 |
| 14548161292054 | K133836 | 000 |
| 14548161292061 | K133836 | 000 |
| 14548161292078 | K133836 | 000 |
| 14548161292085 | K133836 | 000 |
| 14548161292092 | K133836 | 000 |
| 14548161292108 | K133836 | 000 |
| 14548161292115 | K133836 | 000 |
| 14548161282574 | K133836 | 000 |