The following data is part of a premarket notification filed by Chameleon Dental Products, Inc. with the FDA for Mirage Bond.
| Device ID | K884137 |
| 510k Number | K884137 |
| Device Name: | MIRAGE BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | CHAMELEON DENTAL PRODUCTS, INC. 200 NORTH SIXTH ST. Kansas City, KS 66101 |
| Contact | J Sigler,cdt |
| Correspondent | J Sigler,cdt CHAMELEON DENTAL PRODUCTS, INC. 200 NORTH SIXTH ST. Kansas City, KS 66101 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-30 |
| Decision Date | 1988-12-07 |