The following data is part of a premarket notification filed by Prime Dental Manufacturing, Inc. with the FDA for Prime-dent One-step Orthodontic Adhesive Bonding System.
| Device ID | K012673 |
| 510k Number | K012673 |
| Device Name: | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago, IL 60618 |
| Contact | Rolando Marasigan |
| Correspondent | Rolando Marasigan PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago, IL 60618 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-14 |
| Decision Date | 2001-10-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817169020240 | K012673 | 000 |
| 10840326403577 | K012673 | 000 |
| 10840326403607 | K012673 | 000 |
| 10840326403614 | K012673 | 000 |
| 10843471120894 | K012673 | 000 |
| 00842452100491 | K012673 | 000 |
| 00842452100507 | K012673 | 000 |
| 00842452100514 | K012673 | 000 |
| 00842452100521 | K012673 | 000 |
| 00842452100538 | K012673 | 000 |
| 00842452100545 | K012673 | 000 |
| 00842452100552 | K012673 | 000 |
| 00842452100569 | K012673 | 000 |
| 00842452100576 | K012673 | 000 |
| 00842452100583 | K012673 | 000 |
| 00842452100590 | K012673 | 000 |
| 10840326403560 | K012673 | 000 |