CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K011502
Device Name CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM
Original Applicant
CRYSTAL-SEAL DENTAL IMPLANTS
181 valley pkwy.
pelham,, 
AL 
35124

Original Contact clint folsom
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 05/16/2001
Decision Date 10/22/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No