Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Implant, Endosseous, Root-Form
510(k) Number K931767
Device Name ASTRA TECH IMPLANTS-DENTAL SYSTEM
Applicant
Astra Tech, Inc.
1000 Winter St.
Suite 2700
Waltham,  MA  02154
Applicant Contact NIKLAS LIDSKOG
Correspondent
Astra Tech, Inc.
1000 Winter St.
Suite 2700
Waltham,  MA  02154
Correspondent Contact NIKLAS LIDSKOG
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/08/1993
Decision Date 02/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-