The following data is part of a premarket notification filed by Neo Dental Chemical Products Co., Ltd. with the FDA for Evadyne Temporary Crown And Bridge Resin.
| Device ID | K111666 |
| 510k Number | K111666 |
| Device Name: | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
| Contact | Robert Seiple |
| Correspondent | Robert Seiple NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-14 |
| Decision Date | 2011-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560128312578 | K111666 | 000 |