QUANTUM DENTAL IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K112279
Device Name QUANTUM DENTAL IMPLANT SYSTEM
Applicant
QUANTUM BIOENGINEERING, LTD.
11234 el camino real,
suite 200
san diego, 
CA 
92130

Applicant Contact linda schulz
Correspondent
QUANTUM BIOENGINEERING, LTD.
11234 el camino real,
suite 200
san diego, 
CA 
92130

Correspodent Contact linda schulz
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 08/09/2011
Decision Date 05/04/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No