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FDA 510(k)

ZOLLER BURNED LIP CONFORMER

K-Number: K832366 · 1983-09-26

ApplicantUniversal Prosthetics, Inc.
Decision Date1983-09-26
Product CodeEIG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZOLLER BURNED LIP CONFORMER is the device name listed in this FDA 510(k) record. The listed applicant is Universal Prosthetics, Inc.. It received FDA 510(k) clearance on 1983-09-26 under 510(k) number K832366. The device is classified under product code EIG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOLLER BURNED LIP CONFORMER?

ZOLLER BURNED LIP CONFORMER is a medical device that received FDA 510(k) clearance on 1983-09-26. The listed applicant is Universal Prosthetics, Inc.. The 510(k) number is K832366.

When did ZOLLER BURNED LIP CONFORMER receive FDA 510(k) clearance?

ZOLLER BURNED LIP CONFORMER received FDA 510(k) clearance on 1983-09-26, under 510(k) number K832366.

Who is the listed applicant for ZOLLER BURNED LIP CONFORMER?

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

What is the FDA product code for ZOLLER BURNED LIP CONFORMER?

The FDA product code for ZOLLER BURNED LIP CONFORMER is EIG.

Related Clinical Trials

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.

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Other records listing Universal Prosthetics, 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.

K813132THE CHICAGO GULLETK811428NORTHWESTERN VOICE RESTORATION KIT

Related Devices (Code: EIG)

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.

K971284OPALDAMUltradent Products, Inc.K854711FIBRELIGHT ILLUMINATING ORAL RETRACTORSDowns Surgical , Ltd.K821784BEACH GINGIVAL RETRACTION INSTR. TYPE BPacific Dental Corp.K771973GINGITRACTDen-Mat Corp.K771399LIP & CHEEK RETRACTORL.D. Caulk Co.K761024RACESTYPTINE RINGSSeptodont, Inc.

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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