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510(k) K822610

PRECAPSULED DENTAL AMALGAM by Syntex Dental Products, Inc. — Product Code DZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1982
Date Received
August 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Capsule, Dental, Amalgam
Device Class
Class I
Regulation Number
872.3110
Review Panel
DE
Submission Type

Other clearances by Syntex Dental Products, Inc.

  • K832378 — VIBRATORY ENDODONTIC SYSTEM (October 4, 1983)
  • K823230 — STERILE WATER SYSTEM (December 3, 1982)

Other clearances for product code DZS

  • K802967 — DISPERSALLOY-DISPERSED PHASE ALLOY SELF- (December 30, 1980)
  • K781243 — MERCURY DISP. CAPSULE (September 20, 1978)
  • K780966 — LEE-ALLOY DISPOSABLE CAPSULES (August 21, 1978)