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510(k) K863500

STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR by Pacific Union Dental, Inc. — Product Code EIS

K863500 is an FDA 510(k) premarket notification submitted by Pacific Union Dental, Inc. for the device "STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR". The FDA issued a decision of Substantially Equivalent on September 22, 1986. The device falls under product code EIS (Remover, Crown), a Class I device regulated under 21 CFR 872.4565. Pacific Union Dental, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1986
Date Received
September 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Remover, Crown
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Pacific Union Dental, Inc.

  • K860817 — ROOT CANAL ORGANIZER (March 17, 1986)
  • K855113 — FLOSS HOLDER (PLASTIC) (March 6, 1986)
  • K855111 — DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES (March 6, 1986)
  • K855112 — DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS (March 6, 1986)

Other clearances for product code EIS

  • K992649 — ATD AUTOMATIC BRIDGE REMOVER (October 29, 1999)
  • K951299 — EASY PNEUMATIC CROWN AND BRIDGE REMOVER (August 29, 1995)
  • K854795 — HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER (March 4, 1986)
  • K842026 — H-TYPE BRIDGE REMOVER (July 11, 1984)
  • K833290 — C & B 40 PENTRO C & B40 (January 3, 1984)
  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833736 — GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (December 29, 1983)
  • K833278 — C & B 45 (December 29, 1983)
  • K833280 — SUPRA AP CHOICE 83 (December 26, 1983)

FDA data resources