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FDA 510(k)

Sealer Solvent

K-Number: K241354 · 2024-08-27

ApplicantInter-Med, Inc.
Decision Date2024-08-27
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

Sealer Solvent is a medical device manufactured by Inter-Med, Inc.. It received FDA 510(k) clearance on 2024-08-27 under approval number K241354. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sealer Solvent?

Sealer Solvent is a medical device that received FDA 510(k) clearance on 2024-08-27. It is manufactured by Inter-Med, Inc.. The 510(k) number is K241354.

When was Sealer Solvent approved by the FDA?

Sealer Solvent received FDA 510(k) clearance on 2024-08-27, under approval number K241354.

What company makes Sealer Solvent?

Sealer Solvent is manufactured by Inter-Med, Inc..

What is the FDA product code for Sealer Solvent?

The FDA product code for Sealer Solvent is KJJ.

Other Devices by Inter-Med, Inc.

K211721PS System K221811Vista BC Sealer K241457Vista BC Putty K241489ReminGel K253337REGEN Bioactive Cement

Related Devices (Code: KJJ)

K160577PacEndo ChlorhexidinePac-Dent International, Inc. K153528PacEndo EDTAPac-Dent International, Inc. K162311Straumann PrefGelInstitut Straumann AG K173163ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc. K193357V-MixInter-Med/Vista Dental Products K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products

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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