The following data is part of a premarket notification filed by Team Technologies, Inc. with the FDA for Disposable Prophylaxis Angle.
Device ID | K941189 |
510k Number | K941189 |
Device Name: | DISPOSABLE PROPHYLAXIS ANGLE |
Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
Applicant | TEAM TECHNOLOGIES, INC. 5949 COMMERCE BLVD. Morristown, TN 37814 |
Contact | R Watton |
Correspondent | R Watton TEAM TECHNOLOGIES, INC. 5949 COMMERCE BLVD. Morristown, TN 37814 |
Product Code | EGS |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-14 |
Decision Date | 1994-05-16 |