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FDA 510(k)

AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM

K-Number: K954333 · 1995-10-12

ApplicantAmerican Dental Products, Inc.
Decision Date1995-10-12
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM 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 1995-10-12 under 510(k) number K954333. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM?

AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-12. The listed applicant is American Dental Products, Inc.. The 510(k) number is K954333.

When did AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM receive FDA 510(k) clearance?

AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM received FDA 510(k) clearance on 1995-10-12, under 510(k) number K954333.

Who is the listed applicant for AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM?

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 ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM?

The FDA product code for AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM is DYH.

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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: DYH)

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.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

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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