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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

enCore Impression Material

Manufacturer

Date Cleared

2026-03-17

(267 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

Remi Impression Material

Manufacturer

Grindguard, Inc.

Date Cleared

2026-02-25

(266 days)

Product Code

Regulation Number

Type

Panel

Age Range

18 - 71

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The Remi Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums to fabricate patient matched nightguards/mouthguards.

Device Description

The Remi Impression Material is an addition-cure silicone impression material (Type 0 putty consistency) composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry.

AI/ML Overview

N/A

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