Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

REPLICA ACID-ETCH

K-Number: K771883 · 1977-10-20

ApplicantHoyt Laboratories
Decision Date1977-10-20
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPLICA ACID-ETCH is the device name listed in this FDA 510(k) record. The listed applicant is Hoyt Laboratories. It received FDA 510(k) clearance on 1977-10-20 under 510(k) number K771883. 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 REPLICA ACID-ETCH?

REPLICA ACID-ETCH is a medical device that received FDA 510(k) clearance on 1977-10-20. The listed applicant is Hoyt Laboratories. The 510(k) number is K771883.

When did REPLICA ACID-ETCH receive FDA 510(k) clearance?

REPLICA ACID-ETCH received FDA 510(k) clearance on 1977-10-20, under 510(k) number K771883.

Who is the listed applicant for REPLICA ACID-ETCH?

The FDA 510(k) record lists Hoyt Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPLICA ACID-ETCH?

The FDA product code for REPLICA ACID-ETCH is DYH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hoyt Laboratories 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.

K820738LUSTRALLOYK811154HOYT ECONO-TRAYK810830HOYT COTTON ROLLSK780834PREVI DENT PROPHYLAXIS MINT NDCK771881REPLICA BONDING AGENTK771880REPLICA DENTAL COMPOSIT

View all 11 devices →

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.

↑