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FDA 510(k)

VINYLAC PRESS-PACK DENTURE RESIN

K-Number: K831269 · 1983-06-08

ApplicantAstron Dental Corp.
Decision Date1983-06-08
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VINYLAC PRESS-PACK DENTURE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Astron Dental Corp.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831269. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VINYLAC PRESS-PACK DENTURE RESIN?

VINYLAC PRESS-PACK DENTURE RESIN is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Astron Dental Corp.. The 510(k) number is K831269.

When did VINYLAC PRESS-PACK DENTURE RESIN receive FDA 510(k) clearance?

VINYLAC PRESS-PACK DENTURE RESIN received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831269.

Who is the listed applicant for VINYLAC PRESS-PACK DENTURE RESIN?

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

What is the FDA product code for VINYLAC PRESS-PACK DENTURE RESIN?

The FDA product code for VINYLAC PRESS-PACK DENTURE RESIN is EBI.

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 Astron Dental Corp. 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.

K8740252ND MODIFIED VINYLAC PRESS PACK DENTURE RESINK864757MODIFIED VINYLAC PRESS PACK DENTURE RESINK852906DURACLEAN DENTURE CLEANERK833270ASTRON 77 INJECTION DENTURE RESIN

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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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