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FDA 510(k)

SILICONE SPLINTING MATERIAL

K-Number: K840113 · 1985-04-17

ApplicantGeneral Dental Products, Inc.
Decision Date1985-04-17
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILICONE SPLINTING MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is General Dental Products, Inc.. It received FDA 510(k) clearance on 1985-04-17 under 510(k) number K840113. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE SPLINTING MATERIAL?

SILICONE SPLINTING MATERIAL is a medical device that received FDA 510(k) clearance on 1985-04-17. The listed applicant is General Dental Products, Inc.. The 510(k) number is K840113.

When did SILICONE SPLINTING MATERIAL receive FDA 510(k) clearance?

SILICONE SPLINTING MATERIAL received FDA 510(k) clearance on 1985-04-17, under 510(k) number K840113.

Who is the listed applicant for SILICONE SPLINTING MATERIAL?

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

What is the FDA product code for SILICONE SPLINTING MATERIAL?

The FDA product code for SILICONE SPLINTING MATERIAL is MDA.

Related Clinical Trials

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Other records listing General 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.

K823568POLY-TONE DENTURE BASE RESIN

Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, 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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