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FDA 510(k)

STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR

K-Number: K863500 · 1986-09-22

ApplicantPacific Union Dental, Inc.
Decision Date1986-09-22
Product CodeEIS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Union Dental, Inc.. It received FDA 510(k) clearance on 1986-09-22 under 510(k) number K863500. The device is classified under product code EIS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR?

STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR is a medical device that received FDA 510(k) clearance on 1986-09-22. The listed applicant is Pacific Union Dental, Inc.. The 510(k) number is K863500.

When did STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR receive FDA 510(k) clearance?

STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR received FDA 510(k) clearance on 1986-09-22, under 510(k) number K863500.

Who is the listed applicant for STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR?

The FDA 510(k) record lists Pacific Union Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR?

The FDA product code for STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR is EIS.

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Other records listing Pacific Union Dental, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K860817ROOT CANAL ORGANIZERK855112DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYSK855111DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLESK855113FLOSS HOLDER (PLASTIC)

Related Devices (Code: EIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992649ATD AUTOMATIC BRIDGE REMOVERJ. Morita USA, Inc.K951299EASY PNEUMATIC CROWN AND BRIDGE REMOVERDentco, Inc.K854795HAZELTON TEMPORARY CROWN AND BRIDGE REMOVERFran Hazelton Co.K842026H-TYPE BRIDGE REMOVERHiga Manufacturing , Ltd.K833290C & B 40 PENTRO C & B40Genesis Industries, Inc.K833287SATIN CAST ECONOCASTGenesis Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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