The following data is part of a premarket notification filed by Miles Inc., Dental Products with the FDA for Gluma 3 Step Bonding System/ Gluma 3 Primer/desensitizer.
| Device ID | K933360 |
| 510k Number | K933360 |
| Device Name: | GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | MILES INC., DENTAL PRODUCTS 4315 S. LAFAYETTE BLVD. South Bend, IN 46614 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman MILES INC., DENTAL PRODUCTS 4315 S. LAFAYETTE BLVD. South Bend, IN 46614 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-09 |
| Decision Date | 1994-11-22 |