ULTRACAPS S


Device Classification Name

dental amalgam

510(k) Number K081273
Device Name ULTRACAPS S
Applicant
SDI LTD.
5-9 brunsdon st.
bayswater, victoria, 

AU

3153

Applicant Contact ray cahill
Correspondent
SDI LTD.
5-9 brunsdon st.
bayswater, victoria, 

AU

3153

Correspodent Contact ray cahill
Regulation Number 872.3070
Classification Product Code
OIV  
Subsequent Product Codes
EJJ   ELY  
Date Received 05/05/2008
Decision Date 07/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No