The following data is part of a premarket notification filed by Neoss Ltd with the FDA for Neoss Various Titanium Abutments.
Device ID | K071838 |
510k Number | K071838 |
Device Name: | NEOSS VARIOUS TITANIUM ABUTMENTS |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | NEOSS LTD WINDSOR HOUSE, CORNWALL ROAD Harrogate, GB Hgi2pw |
Contact | Fredrik Engman |
Correspondent | Fredrik Engman NEOSS LTD WINDSOR HOUSE, CORNWALL ROAD Harrogate, GB Hgi2pw |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-05 |
Decision Date | 2007-10-19 |
Summary: | summary |