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510(k) K832378

VIBRATORY ENDODONTIC SYSTEM by Syntex Dental Products, Inc. — Product Code EKQ

K832378 is an FDA 510(k) premarket notification submitted by Syntex Dental Products, Inc. for the device "VIBRATORY ENDODONTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code EKQ (Preparer, Root Canal Endodontic), a Class I device regulated under 21 CFR 872.4565. Syntex Dental Products, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
July 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Preparer, Root Canal Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Syntex Dental Products, Inc.

  • K823230 — STERILE WATER SYSTEM (December 3, 1982)
  • K822610 — PRECAPSULED DENTAL AMALGAM (September 14, 1982)

Other clearances for product code EKQ

  • K801463 — OJ-1 ENDODONIC ROOT CANAL FILE HOLDER (July 21, 1980)

FDA data resources