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FDA 510(k)

ORMCO GEL-ETCH

K-Number: K871591 · 1987-05-18

ApplicantScientific Pharmaceuticals, Inc.
Decision Date1987-05-18
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORMCO GEL-ETCH is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1987-05-18 under 510(k) number K871591. 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 ORMCO GEL-ETCH?

ORMCO GEL-ETCH is a medical device that received FDA 510(k) clearance on 1987-05-18. The listed applicant is Scientific Pharmaceuticals, Inc.. The 510(k) number is K871591.

When did ORMCO GEL-ETCH receive FDA 510(k) clearance?

ORMCO GEL-ETCH received FDA 510(k) clearance on 1987-05-18, under 510(k) number K871591.

Who is the listed applicant for ORMCO GEL-ETCH?

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

What is the FDA product code for ORMCO GEL-ETCH?

The FDA product code for ORMCO GEL-ETCH is DYH.

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Other records listing Scientific Pharmaceuticals, 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.

K051952EUGENONEK041886PROVISOK013555SCI-PHARM POST SECUREK001446LIGHT-CURED ORTHODONTIC BAND CEMENTK993324CARBOCEM ZINC POLYCARBOXYLATE CEMENTK982915SCI-PHARM DFV VARNISH

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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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