510(k) K972234

RCT GEL ROOT CANAL THERAPY GEL by Dentsply Intl. — Product Code EIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1997
Date Received
June 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Periodontic, Endodontic, Irrigating
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type