The following data is part of a premarket notification filed by Dentca, Inc. with the FDA for Dentca Denture Base Ii.
Device ID | K162044 |
510k Number | K162044 |
Device Name: | Dentca Denture Base II |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | DENTCA, Inc. 357 Van Ness Way #250 Torrance, CA 90501 |
Contact | Jason Lee |
Correspondent | Claude Berthoin Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-25 |
Decision Date | 2017-03-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856551007278 | K162044 | 000 |
J01466075560 | K162044 | 000 |
00810002220128 | K162044 | 000 |
00856551007001 | K162044 | 000 |
00856551007209 | K162044 | 000 |
00856551007216 | K162044 | 000 |
00856551007230 | K162044 | 000 |
00856551007247 | K162044 | 000 |
00856551007254 | K162044 | 000 |
00856551007261 | K162044 | 000 |
J01466075558 | K162044 | 000 |