The following data is part of a premarket notification filed by Cheng & Assoc., Inc. with the FDA for Hurriseal Dentin Desensitizer.
| Device ID | K973002 |
| 510k Number | K973002 |
| Device Name: | HURRISEAL DENTIN DESENSITIZER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | CHENG & ASSOC., INC. 415 W. ALDINE AVENUE, #10-A Chicago, IL 60652 |
| Contact | An-shih Cheng |
| Correspondent | An-shih Cheng CHENG & ASSOC., INC. 415 W. ALDINE AVENUE, #10-A Chicago, IL 60652 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-12 |
| Decision Date | 1998-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 02723797697113 | K973002 | 000 |
| 01723797697824 | K973002 | 000 |
| 01723797697145 | K973002 | 000 |
| 10723797697822 | K973002 | 000 |
| 10723797697143 | K973002 | 000 |