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FDA 510(k)

SOLARCRYL CUSTOM TRAY MATERIAL

K-Number: K831293 · 1983-07-26

ApplicantSolar Dental Co., Inc.
Decision Date1983-07-26
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLARCRYL CUSTOM TRAY MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Solar Dental Co., Inc.. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K831293. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLARCRYL CUSTOM TRAY MATERIAL?

SOLARCRYL CUSTOM TRAY MATERIAL is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Solar Dental Co., Inc.. The 510(k) number is K831293.

When did SOLARCRYL CUSTOM TRAY MATERIAL receive FDA 510(k) clearance?

SOLARCRYL CUSTOM TRAY MATERIAL received FDA 510(k) clearance on 1983-07-26, under 510(k) number K831293.

Who is the listed applicant for SOLARCRYL CUSTOM TRAY MATERIAL?

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

What is the FDA product code for SOLARCRYL CUSTOM TRAY MATERIAL?

The FDA product code for SOLARCRYL CUSTOM TRAY MATERIAL is EBH.

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.

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Other records listing Solar Dental Co., 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.

K871980D-23 DENTURE ADHESIVEK861846HYDRON ROOT CANAL FILLING & MARK IV STARTER KITK852926DENTOLOCK II DENTURE ADHESIVE CREAMK831294SOLARCRY/TEMPORARY CROWN & BRIDGE MATK831265DENTOLOCK DENTURE ADHESIVE CREAM

Related Devices (Code: EBH)

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.

K933745PERMAGEN UNIVERSAL BONDING RESINBio-Systems ResearchK930487PALATRAY LC MINTHeraeus Kulzer, Inc.K923979LC TRAY MATERIALDentsply Intl.K923549PALADISC LCHeraeus Kulzer, Inc.K912820POLYESTER RESIN HAND MOLDED TRAYE&D Dental Products, Inc.K905058PALAVIT LKulzer, 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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