The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for Dentatus L Set.
Device ID | K863016 |
510k Number | K863016 |
Device Name: | DENTATUS L SET |
Classification | Chair, Dental, With Operative Unit |
Applicant | SDS DENTAL, INC. 4321 WISCONSIN AVE N.W SUITE 200 Washington, DC 20016 |
Contact | Cesar Coral |
Correspondent | Cesar Coral SDS DENTAL, INC. 4321 WISCONSIN AVE N.W SUITE 200 Washington, DC 20016 |
Product Code | KLC |
CFR Regulation Number | 872.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-08 |
Decision Date | 1986-10-01 |