FDA.reportPublic FDA data

Tokuyama Shield Force Plus

Primary DI
04548190151219
Brand
Tokuyama Shield Force Plus
Company
TOKUYAMA DENTAL CORPORATION
Model
15121
Device description
Refill
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100172000TOKUYAMA SHIELD FORCETokuyama Dental Corporation2010-10-21LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548190151219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548190151219045481901512194548190151219

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-378-3548info@tokuyama-us.com

Regulatory Flags#

DUNS number
693552176
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04548190201723TOKUSO Resin Hardner II201722021-06-25
04548190102228OMNICHROMA BLOCKER FLOW102222020-03-31
04548190101177OMNICHROMA BLOCKER101172018-09-10
04548190101276OMNICHROMA BLOCKER101272018-09-10
04548190101313OMNICHROMA BLOCKER101312018-04-02
04548190101337OMNICHROMA BLOCKER101332018-05-15
04548190101412OMNICHROMA101412018-09-10
04548190101511OMNICHROMA101512018-09-10
04548190131105Estelite Sigma Quick 131102016-09-23
04548190131112Estelite Sigma Quick 131112016-09-23
04548190131129Estelite Sigma Quick 131122016-09-23
04548190131136Estelite Sigma Quick131132016-09-23
04548190131143Estelite Sigma Quick 131142016-09-23
04548190131150Estelite Sigma Quick 131152016-09-23
04548190131167Estelite Sigma Quick131162016-09-23
04548190131174Estelite Sigma Quick 131172016-09-23
04548190131181Estelite Sigma Quick 131182016-09-23
04548190131198Estelite Sigma Quick 131192016-09-23
04548190131204Estelite Sigma Quick 131202016-09-23

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506058610873033M™ Clinpro™3M COMPANYLBH2025-10-15
10818207025064ReminGelVista DentalLBH2025-10-09
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07615208292893Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-03-20
00302730003178D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003192D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003208D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003215D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003222D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
07615208474459Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-04-05
07615208474091Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-03-25
106058610839633M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839703M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839873M™ Clinpro™3M COMPANYLBH2023-12-14
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10810111542873FluoroCalBISCO INC.LBH2023-12-11
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20035000992974Toms Sensitive + Whitening Fluoride-Free Toothpaste TOM'S OF MAINE, INC.LBH2023-06-02
20810063753928Safco CleanCare Essential Prophy PasteSAFCO DENTAL SUPPLY CO.LBH2022-12-02