The following data is part of a premarket notification filed by Dental Air Solutions Of Nc, Inc. with the FDA for Clearview Dental Handpiece Lubricator And Lubricant.
Device ID | K070297 |
510k Number | K070297 |
Device Name: | CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT |
Classification | Handpiece, Air-powered, Dental |
Applicant | DENTAL AIR SOLUTIONS OF NC, INC. 224 BRANCHSIDE LANE Holly Springs, NC 27540 |
Contact | Thomas Fee |
Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-01-31 |
Decision Date | 2007-02-05 |
Summary: | summary |