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510(k) K933612

JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) by Jedental Co., Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1994
Date Received
July 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Jedental Co., Inc.

  • K934073 — JEDENTAL GLASS IONOMER CEMENT AND LINER (January 26, 1994)
  • K935718 — JEDENTAL VLC DENTAL CURING LIGHT (January 26, 1994)
  • K935727 — P&FS PIT AND FISSURE SEALANT (January 21, 1994)
  • K933656 — JEDENTAL PSROFILL SELF-CURE COMPOSITE (November 17, 1993)
  • K933543 — ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) (November 1, 1993)
  • K933554 — JEDENTAL ZINC CEMENT IMPROVED (November 1, 1993)
  • K931880 — PROFILL LC COMPOSITE (July 8, 1993)

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