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FDA 510(k)

REPLICA DENTAL COMPOSIT

K-Number: K771880 · 1977-10-20

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

Device Summary

REPLICA DENTAL COMPOSIT 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 K771880. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPLICA DENTAL COMPOSIT?

REPLICA DENTAL COMPOSIT 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 K771880.

When did REPLICA DENTAL COMPOSIT receive FDA 510(k) clearance?

REPLICA DENTAL COMPOSIT received FDA 510(k) clearance on 1977-10-20, under 510(k) number K771880.

Who is the listed applicant for REPLICA DENTAL COMPOSIT?

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 DENTAL COMPOSIT?

The FDA product code for REPLICA DENTAL COMPOSIT is EBF.

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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 AGENTK771882REPLICA DENTAL COMPOSITE-RADIOPAQUE

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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