510(k) K851712

600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI by Artiberia — Product Code EMG

K851712 is an FDA 510(k) premarket notification submitted by Artiberia for the device "600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code EMG (Forceps, Tooth Extractor, Surgical), a Class I device regulated under 21 CFR 872.4565. Artiberia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Tooth Extractor, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type