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510(k) K853160

AUSTENAL MODIFIED ACRYLIC DENTURE RESIN by Austenal Dental, Inc. — Product Code ELM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1985
Date Received
July 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Denture, Plastic, Teeth
Device Class
Class II
Regulation Number
872.3590
Review Panel
DE
Submission Type

Other clearances by Austenal Dental, Inc.

  • K890713 — OVERDENTURE - STUD ATTACHMENT (July 14, 1989)
  • K883799 — BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN (October 20, 1988)
  • K880875 — VITALLIUM EQUIPOISE ALLOY (April 7, 1988)
  • K871849 — LIGHT CURE DENTURE GLAZE (August 10, 1987)
  • K872746 — VITALLIUM WIRE (July 21, 1987)
  • K863630 — AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL (March 11, 1987)
  • K862557 — AUSTENAL ACUSOFT SOFT LINER (February 19, 1987)
  • K865025 — AUSTENAL CONDENSING INSTRUMENT (February 19, 1987)
  • K864826 — A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) (February 10, 1987)
  • K862856 — PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR (August 26, 1986)

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  • K122925 — NEW STETIC ARTIFICIAL TEETH (February 12, 2013)
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  • K120404 — MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH (May 21, 2012)
  • K120736 — SR PHONARES II (May 14, 2012)
  • K113426 — VERACIA SA (February 8, 2012)
  • K101064 — BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (September 14, 2010)
  • K101029 — KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYM (August 16, 2010)