SYNEA-HS HIGH SPEED-HANDPIECE


Device Classification Name

handpiece, air-powered, dental

510(k) Number K992011
Device Name SYNEA-HS HIGH SPEED-HANDPIECE
Applicant
A-DEC, INC.
2601 crestview dr.
newberg, 
OR 
97132 -9257

Applicant Contact patrick ridenour
Correspondent
A-DEC, INC.
2601 crestview dr.
newberg, 
OR 
97132 -9257

Correspodent Contact patrick ridenour
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 06/15/1999
Decision Date 09/10/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No