• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name abutment, implant, dental, endosseous
510(k) Number K023631
Device Name ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
Applicant
ASTRA TECH, INC.
96 WEST MAIN ST.
P.O. BOX 809
NORTHBOROUGH,  MA  01532
Applicant Contact BRUCE R MANNING
Correspondent
ASTRA TECH, INC.
96 WEST MAIN ST.
P.O. BOX 809
NORTHBOROUGH,  MA  01532
Correspondent Contact BRUCE R MANNING
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/29/2002
Decision Date 11/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-