PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM


Device Classification Name

agent, tooth bonding, resin

510(k) Number K050386
Device Name PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
Applicant
DENTSPLY INTERNATIONAL
221 w. philadelphia st.
suite 60
york, 
PA 
17404

Applicant Contact helen lewis
Correspondent
DENTSPLY INTERNATIONAL
221 w. philadelphia st.
suite 60
york, 
PA 
17404

Correspodent Contact helen lewis
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 02/15/2005
Decision Date 02/23/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Special
Reviewed by Third Party No

Combination Product

No