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Found 7 results
510(k) Data Aggregation
K Number
K241489Device Name
ReminGel
Manufacturer
Inter-Med, Inc.
Date Cleared
2025-01-08
(229 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
Inter-Med, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.
Device Description
ReminGel is a convenient, premixed, ready-to-use, opaque aqueous-based gel. ReminGel consists of suspended hydroxyapatite and calcium and phosphate salts that help restore a tooth's hydroxyapatite structure through remineralization. This remineralization results in tubule occlusion and blocks fluid flow in dentinal tubules, thereby relieving dentinal sensitivity. ReminGel blocks nerve excitability through potassium release. ReminGel is packaged in a 3oz (90mL) tube. ReminGel is for prescription use (Rx) and over-the-counter (OTC) use. ReminGel can be applied to teeth using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush.
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K Number
K241457Device Name
Vista BC Putty
Manufacturer
Inter-Med, Inc.
Date Cleared
2024-08-28
(97 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Inter-Med, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
Device Description
Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties.
1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.
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K Number
K241354Device Name
Sealer Solvent
Manufacturer
Inter-Med, Inc.
Date Cleared
2024-08-27
(106 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Inter-Med, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sealer Solvent, a root canal cleanser, is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy.
Device Description
The Sealer Solvent presents a clinically effective way to aid in removal of bioceramic root canal sealers during endodontic retreatment procedures. Sealer Solvent is an aqueous-based irrigant that is delivered via syringe and needle tip while instrumenting the canal after any gutta percha is removed. Sealer solvent works to soften and dissolve the sealer to be flushed out or removed with files. Although Sealer Solvent has been designed for use as a retreatment irrigant, it may be used during traditional endodontic non-retreatment procedures as an endodontic irrigant (i.e. root canal cleanser) to help remove inorganic solids from canal walls, such as smear layer and calcium hydroxide, prior to obturation.
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K Number
K221811Device Name
Vista BC Sealer
Manufacturer
Inter-Med, Inc.
Date Cleared
2022-11-21
(152 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Inter-Med, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent obturation of the root canal following vital pulp-extirpation.
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Device Description
Vista BC Sealer is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. Vista BC Sealer is an insoluble, radiopaque material based on a calcium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Sealer does not appreciably shrink during setting and demonstrates excellent physical properties. Vista BC Sealer is packaged in a preloaded syringe and supplied with disposable single use application tips.
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K Number
K211721Device Name
PS System
Manufacturer
Inter-Med, INC.
Date Cleared
2021-12-02
(181 days)
Product Code
NYL
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Inter-Med, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
Device Description
The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.
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K Number
K112250Device Name
CHX=CHX PLUS
Manufacturer
INTER-MED, INC.
Date Cleared
2011-10-28
(85 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INTER-MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CHX and CHX-Plus™ are used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing
Device Description
CHX and CHX-PlusTM are 2% Chlorhexidine Gluconate Solutions in water. CHX – PlusTM also contains wetting agents to lower surface tension. CHX and CHX-PlusTM are root canal cleansers for use in endodontic procedures. After endodontic instrumentation, these products should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating needle
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K Number
K082470Device Name
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
Manufacturer
INTER-MED, INC.
Date Cleared
2009-04-03
(219 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INTER-MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM are solutions used for debridement and the instrumentation of root canal. Sodium Hypochlorite-3% & 6% and Chlor-XTRATM 6% are Sodium Hypochlorite in water.
Device Description
Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium Hypochlorite in water.
Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM is a Sodium Hypochlorite solution in water with alkalizing salt agents to increase the electrical capacity of the solution.
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