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FDA 510(k)

SHAPING HEDSTROM N.T.

K-Number: K953604 · 1995-09-28

ApplicantSybron Dental Specialties, Inc.
Decision Date1995-09-28
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SHAPING HEDSTROM N.T. is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1995-09-28 under 510(k) number K953604. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAPING HEDSTROM N.T.?

SHAPING HEDSTROM N.T. is a medical device that received FDA 510(k) clearance on 1995-09-28. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K953604.

When did SHAPING HEDSTROM N.T. receive FDA 510(k) clearance?

SHAPING HEDSTROM N.T. received FDA 510(k) clearance on 1995-09-28, under 510(k) number K953604.

Who is the listed applicant for SHAPING HEDSTROM N.T.?

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

What is the FDA product code for SHAPING HEDSTROM N.T.?

The FDA product code for SHAPING HEDSTROM N.T. is EKS.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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Related Devices (Code: EKS)

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.

K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK935542NICKEL-TITANIUM K-TYPE FILEUnion Broach, Div. Moyco 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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