The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Unitek Ceramic Bracket System.
| Device ID | K861965 |
| 510k Number | K861965 |
| Device Name: | UNITEK CERAMIC BRACKET SYSTEM |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Contact | Jerold S Horn |
| Correspondent | Jerold S Horn UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-19 |
| Decision Date | 1986-06-09 |