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FDA 510(k)

POLY-TONE DENTURE BASE RESIN

K-Number: K823568 · 1983-01-12

ApplicantGeneral Dental Products, Inc.
Decision Date1983-01-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLY-TONE DENTURE BASE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is General Dental Products, Inc.. It received FDA 510(k) clearance on 1983-01-12 under 510(k) number K823568. 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 POLY-TONE DENTURE BASE RESIN?

POLY-TONE DENTURE BASE RESIN is a medical device that received FDA 510(k) clearance on 1983-01-12. The listed applicant is General Dental Products, Inc.. The 510(k) number is K823568.

When did POLY-TONE DENTURE BASE RESIN receive FDA 510(k) clearance?

POLY-TONE DENTURE BASE RESIN received FDA 510(k) clearance on 1983-01-12, under 510(k) number K823568.

Who is the listed applicant for POLY-TONE DENTURE BASE RESIN?

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

What is the FDA product code for POLY-TONE DENTURE BASE RESIN?

The FDA product code for POLY-TONE DENTURE BASE RESIN is EBI.

Related Clinical Trials

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Other records listing General Dental Products, 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.

K840113SILICONE SPLINTING MATERIAL

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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