The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Transbond Light Cured Orthodontic Adhesive.
| Device ID | K880393 |
| 510k Number | K880393 |
| Device Name: | TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Contact | Marlyn Scheff |
| Correspondent | Marlyn Scheff UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-29 |
| Decision Date | 1988-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00652221109071 | K880393 | 000 |
| D8281330606 | K880393 | 000 |
| D8281330610 | K880393 | 000 |
| 00652221108906 | K880393 | 000 |
| 00652221108913 | K880393 | 000 |
| 00652221108937 | K880393 | 000 |
| 00652221108944 | K880393 | 000 |
| 00652221108951 | K880393 | 000 |
| 00652221108975 | K880393 | 000 |
| 00652221109002 | K880393 | 000 |
| D8281330603 | K880393 | 000 |