The following data is part of a premarket notification filed by Pacific Dental Corp. with the FDA for Torx Handpiece Contra Angles Attachments.
Device ID | K801688 |
510k Number | K801688 |
Device Name: | TORX HANDPIECE CONTRA ANGLES ATTACHMENTS |
Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
Applicant | PACIFIC DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EGS |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-21 |
Decision Date | 1980-08-04 |