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 K982111
Device Name VARIOUS DENTAL IMPLANTS
Applicant
Biotech Medical Instruments Corp.
832 Marseilles- Galion Rdw
Marion,  OH  43302
Applicant Contact WILLIAM SIMMONS
Correspondent
Biotech Medical Instruments Corp.
832 Marseilles- Galion Rdw
Marion,  OH  43302
Correspondent Contact WILLIAM SIMMONS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/16/1998
Decision Date 09/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-