The following data is part of a premarket notification filed by Dmp Ltd with the FDA for Dmp Single Bonding.
| Device ID | K102254 |
| 510k Number | K102254 |
| Device Name: | DMP SINGLE BONDING |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DMP LTD KALYVION AVENUE MARKOPOULO INDUSTRIAL ZONE Markopoulo, Attiki, GR 19003 |
| Contact | Dimitris Prantsidis |
| Correspondent | Dimitris Prantsidis DMP LTD KALYVION AVENUE MARKOPOULO INDUSTRIAL ZONE Markopoulo, Attiki, GR 19003 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-10 |
| Decision Date | 2010-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816577022327 | K102254 | 000 |
| 00817800020660 | K102254 | 000 |