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FDA 510(k)

AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA

K-Number: K954876 · 1995-11-15

ApplicantAmerican Dental Products, Inc.
Decision Date1995-11-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA 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 1995-11-15 under 510(k) number K954876. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA?

AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA is a medical device that received FDA 510(k) clearance on 1995-11-15. The listed applicant is American Dental Products, Inc.. The 510(k) number is K954876.

When did AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA receive FDA 510(k) clearance?

AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA received FDA 510(k) clearance on 1995-11-15, under 510(k) number K954876.

Who is the listed applicant for AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA?

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 ROOT CANAL SEALER, WACH'S FORMULA?

The FDA product code for AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA is EMA.

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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 FLUORIDEK954637AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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