The following data is part of a premarket notification filed by Dharma Research, Inc. with the FDA for Jade 37% Phosphoric Acid Etchant Gel.
| Device ID | K150696 |
| 510k Number | K150696 |
| Device Name: | Jade 37% Phosphoric Acid Etchant Gel |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Dharma Research, Inc. 5220 NW 72nd Ave #15 Miami, FL 33166 |
| Contact | Ricardo Carles |
| Correspondent | Ricardo Carles Dharma Research, Inc. 5220 NW 72nd Ave #15 Miami, FL 33166 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-18 |
| Decision Date | 2015-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D77819910141 | K150696 | 000 |
| 10353045000632 | K150696 | 000 |
| 10353045000649 | K150696 | 000 |
| 10353045000656 | K150696 | 000 |
| 10353045000663 | K150696 | 000 |
| 10353045000670 | K150696 | 000 |
| 10353045000687 | K150696 | 000 |
| 10353045000694 | K150696 | 000 |
| 10353045000700 | K150696 | 000 |
| 00353045000710 | K150696 | 000 |
| 10353045002124 | K150696 | 000 |
| 10353045002131 | K150696 | 000 |
| D77819910111 | K150696 | 000 |
| D77819910121 | K150696 | 000 |
| D77819910131 | K150696 | 000 |
| 10353045000625 | K150696 | 000 |