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FDA 510(k)

AMERICAN DENTAL PRODUCTS ETCH-DETECT

K-Number: K991099 · 1999-06-10

ApplicantAmerican Dental Products, Inc.
Decision Date1999-06-10
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMERICAN DENTAL PRODUCTS ETCH-DETECT 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 1999-06-10 under 510(k) number K991099. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN DENTAL PRODUCTS ETCH-DETECT?

AMERICAN DENTAL PRODUCTS ETCH-DETECT is a medical device that received FDA 510(k) clearance on 1999-06-10. The listed applicant is American Dental Products, Inc.. The 510(k) number is K991099.

When did AMERICAN DENTAL PRODUCTS ETCH-DETECT receive FDA 510(k) clearance?

AMERICAN DENTAL PRODUCTS ETCH-DETECT received FDA 510(k) clearance on 1999-06-10, under 510(k) number K991099.

Who is the listed applicant for AMERICAN DENTAL PRODUCTS ETCH-DETECT?

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 ETCH-DETECT?

The FDA product code for AMERICAN DENTAL PRODUCTS ETCH-DETECT is EBC.

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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.

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Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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