The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for M.l. Primer.
| Device ID | K040079 |
| 510k Number | K040079 |
| Device Name: | M.L. PRIMER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Contact | David P Morais |
| Correspondent | David P Morais SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-15 |
| Decision Date | 2004-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23517400 | K040079 | 000 |