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Found 29 results
510(k) Data Aggregation
K Number
K230270Device Name
3M VitCal Liner/Base
Manufacturer
3M ESPE Dental Products
Date Cleared
2023-02-06
(6 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping.
Device Description
3M VitCal liner/base is a two-part paste/paste, light-cured system. The paste/paste materials are contained in a Micro-Mix Syringe Dispensing System. This dispensing system provides simultaneous dispensing and mixing of each component for a consistent mix and direct application into the mouth. The composition is a combination of a resin-modified glass ionomer and calcium-based material. The first paste contains a radiopaque fluoro-aluminosilicate glass and calcium filler. The second paste contains a modified polyalkenoic acid. VitCal liner/base provides the major benefits of glass ionomer cements including adhesion to the tooth structure and sustained fluoride release. Additionally, VitCal linerbase offers a high pH environment and a combination of a prolonged working time with an on-demand set time achieved by light curing.
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K Number
K212475Device Name
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
Manufacturer
Prevest Denpro Limited
Date Cleared
2022-05-13
(280 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Apacal ART and is suitable for several indications including:
- · Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials.
- · Indirect pulp capping or management of deep caries lesions, or
- · Direct pulp capping
CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled.
Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including;
- · Indirect pulp capping or management of deep caries lesions, or
· Direct pulp capping
CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
Device Description
Apacal ART is a light cured single-component paste reinforced with tricalcium phosphate and hydroxyapatite. It is sold in a syringe with accompanying applicator tips.
CAL-LC is a highly filled cavity liner and pulp capping material. It is sold in a syringe with accompanying applicator tips.
Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. It is syringe with accompanying applicator tips.
CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent. CalUltra is a two-part base/catalyst paste/paste system. It is sold in a tubes with accompanying spatula and mixing pad.
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K Number
K201799Device Name
CleaniCal
Manufacturer
Maruchi
Date Cleared
2021-02-12
(227 days)
Product Code
EJK, KIF
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including:
* Temporary disinfectant dressings in the obturation of root canals;
* Indirect pulp capping or management of deep caries lesions; or
* Direct pulp capping.
Device Description
CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3.
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K Number
K202413Device Name
LC ResinCal PC
Manufacturer
S&C Polymer Silicon- und Composite Spezialitaten GmbH
Date Cleared
2020-11-20
(88 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Pulp capping agent
2. Liner
Device Description
Resin modified light cure pulp capping material / liner (indications from labeling).
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K Number
K191103Device Name
Parkell Desensitizer Gel
Manufacturer
Parkell, Inc.
Date Cleared
2019-11-22
(211 days)
Product Code
EJK, LBH
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments:
- · treatment of dentin exposed by toothbrush abrasion, periodontal disease, and/or acid erosion;
- · treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
- · treatment of tooth hypersensitivity associated with bleaching: and
- · treatment of prepared dentin for fillings and/or prosthetic restorations.
Device Description
Parkell® Desensitizer Gel alleviates dental hypersensitivity at treatment sites. It is a gel which requires no mixing prior to use and which is applied to treatment sites using a standard applicator brush. Parkell® Desensitizer releases calcium and phosphate ions at the treatment site and stimulates hydroxyapatite formation on the surface of treated dentin and in dentinal tubules. In this manner, the Device hardens following application and forms a layer of mineral hydroxyapatite as well as hydroxyapatite plugs which occlude dentinal tubules, which results in the treatment of dental hypersensitivity.
Parkell® Desensitizer Gel is packaged in any standard single-chamber syringe. The syringe is accompanied by standard snap-in tips and standard applicator brushes.
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K Number
K180344Device Name
TheraCal DC
Manufacturer
Bisco, Inc.
Date Cleared
2018-04-05
(56 days)
Product Code
EJK, CLA
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TheraCal DC is indicated for use for:
1. Pulpotomy
2. Temporary Filling Material
3. Repair of Root Perforations
4. Repair of Furcation Perforations
5. Repair of Perforating Internal and External Resorptions
6. Root-End Filling in Endodontic Surgery
7. Pulp Exposures (Direct Pulp Capping)
8. Protective Liner (Indirect Pulp Capping) and Base for Use Under a Variety of Substrates
Device Description
TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
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K Number
K143292Device Name
TheraCal DC
Manufacturer
Bisco Inc
Date Cleared
2015-08-04
(260 days)
Product Code
EJK, CLA
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TheraCal DC is indicated for use for:
- 1. Pulpotomy
- 2. Temporary filling material
- 3. Repair of root perforations
- Repair of furcation perforations 4.
- 5. Repair of perforating internal and external resorptions
- 6. Root-end filling in endodontic surgery
- 7. Pulp exposures (direct pulp capping)
- 8. Protective liner (Indirect Pulp Capping) and Base for use under a variety of substrates
Device Description
TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
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K Number
K150559Device Name
Life Fast Set, Life Regular Set
Manufacturer
SYBRON DENTAL SPECIALTIES
Date Cleared
2015-06-19
(105 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Life Fast Set/ Life Regular Set is a hard-setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
Device Description
Life Regular Set/Life Fast Set are hard setting Calcium Hydroxide cavity liners and pulp capping agents to be used in conjunction with all permanent restorative techniques. Life is a two-part, base/catalyst- paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Fast Set and Regular Set.
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K Number
K141047Device Name
LC CALCIUMHYDROXIDE LINER
Manufacturer
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN
Date Cleared
2015-04-14
(356 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LC Calcium Hydroxide Liner is intended for:
- Application to dentin as a protective barrier between restorative materials and deep vital dentin (indirect pulp capping)
- lining of cavities for following filling procedures
Device Description
LC Calcium Hydroxide Liner is a radiopaque one component visible light curing liner containing calcium hydroxide. It is intended for indirect pulp capping and for lining of cavities where filling procedures will follow and can be applied in thin layers followed by light curing of the material. The chemical components include fillers, resins, an alkalining agent, as well an initiator.
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K Number
K134022Device Name
BASE IT
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2014-06-11
(163 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Product Code :
EJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Base it is a light-cured, radiopaque dental liner and base material that Contains calcium bydroxyl apatite in a urethane dimethacrylate oligomer. Base it is used to line cavity preparations before restoration.
Device Description
Base it is light-cured Cavity Liner. It is radiopaque cavity liner and base material specially formulated for use with adhesives, composites and conventional restorative materials. It has urethane dimethacrylate base and is similar in chemistry to dental composites.
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