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FDA 510(k)

PREFORMED TOOTH ARCH

K-Number: K852981 · 1985-08-16

ApplicantSwipes Dental Laboratory
Decision Date1985-08-16
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREFORMED TOOTH ARCH is the device name listed in this FDA 510(k) record. The listed applicant is Swipes Dental Laboratory. It received FDA 510(k) clearance on 1985-08-16 under 510(k) number K852981. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREFORMED TOOTH ARCH?

PREFORMED TOOTH ARCH is a medical device that received FDA 510(k) clearance on 1985-08-16. The listed applicant is Swipes Dental Laboratory. The 510(k) number is K852981.

When did PREFORMED TOOTH ARCH receive FDA 510(k) clearance?

PREFORMED TOOTH ARCH received FDA 510(k) clearance on 1985-08-16, under 510(k) number K852981.

Who is the listed applicant for PREFORMED TOOTH ARCH?

The FDA 510(k) record lists Swipes Dental Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREFORMED TOOTH ARCH?

The FDA product code for PREFORMED TOOTH ARCH is ELM.

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Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

Official Source

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

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