The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Products Hb-35 Desensitizer With Fluoride.
| Device ID | K973185 |
| 510k Number | K973185 |
| Device Name: | AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | AMERICAN DENTAL PRODUCTS, INC. 22 W 246 SUNNYSIDE RD. Medinah, IL 60157 -9705 |
| Contact | George Nicolae |
| Correspondent | George Nicolae AMERICAN DENTAL PRODUCTS, INC. 22 W 246 SUNNYSIDE RD. Medinah, IL 60157 -9705 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1997-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865849000242 | K973185 | 000 |
| 00865849000228 | K973185 | 000 |
| 00865849000211 | K973185 | 000 |
| 00865849000204 | K973185 | 000 |