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FDA 510(k)

AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER

K-Number: K954637 · 1995-12-28

ApplicantAmerican Dental Products, Inc.
Decision Date1995-12-28
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER is the device name listed in this FDA 510(k) record. The listed applicant is American Dental Products, Inc.. It received FDA 510(k) clearance on 1995-12-28 under 510(k) number K954637. 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 AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER?

AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER is a medical device that received FDA 510(k) clearance on 1995-12-28. The listed applicant is American Dental Products, Inc.. The 510(k) number is K954637.

When did AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER receive FDA 510(k) clearance?

AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER received FDA 510(k) clearance on 1995-12-28, under 510(k) number K954637.

Who is the listed applicant for AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER?

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

What is the FDA product code for AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER?

The FDA product code for AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER is EBI.

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Other records listing American 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.

K093014AMERICAN DENTAL PRODUCTS SE BONDEASYK994368AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUSK991099AMERICAN DENTAL PRODUCTS ETCH-DETECTK973185AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDEK964133AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDEK954876AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA

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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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