The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Ecliptomer.
| Device ID | K945604 |
| 510k Number | K945604 |
| Device Name: | ECLIPTOMER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Contact | James L Sandrik |
| Correspondent | James L Sandrik BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-15 |
| Decision Date | 1995-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8281330225 | K945604 | 000 |
| D867CLABP0 | K945604 | 000 |