FDA.reportPublic FDA data

SmartMTA Capsule

Primary DI
00819235022196
Brand
SmartMTA Capsule
Company
Sprig Oral Health Technologies, Inc.
Model
R-MTA-C20
Device description
SmartMTA Capsule - 20 pack
Published
2023-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KIFResin, Root Canal Filling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIFResin, Root Canal FillingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230797000SmartMTA CapsuleSprig Oral Health Technologies, Inc.2023-03-24KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819235022196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819235022196008192350221968192350221960819235022196

GMDN Terms#

Term, Definition table
TermDefinition
Hygroscopic dental cementA substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
029458526
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819235022189SmartMTA Capsule R-MTA-C102023-05-18
00819235020093EZCrownR-EZC-A-PK2022-12-05
00819235020109EZCrownR-EZC-A-SK2022-12-05
00819235020116EZCrownR-EZC-MAN-MK2022-12-05
00819235020123EZCrownR-EZC-MAN-PK2022-12-05
00819235020130EZCrownR-EZC-MAN-SK2022-12-05
00819235020147EZCrownR-EZC-MAX-SK2022-12-05
00819235020154EZCrownR-EZC-MAX-MK2022-12-05
00819235020161EZCrown R-EZC-MAX-PK2022-12-05
00819235020086EZCrownR-EZC-A-MK2022-12-01
00819235020192EZCrownR-EZC-P-A22022-12-01
00819235020208EZCrownR-EZC-P-A2SL2022-12-01
00819235020215EZCrownR-EZC-P-A32022-12-01
00819235020222EZCrownR-EZC-P-A3SL2022-12-01
00819235020239EZCrownR-EZC-P-A42022-12-01
00819235020246EZCrownR-EZC-P-A4SL2022-12-01
00819235020253EZCrownR-EZC-P-A52022-12-01
00819235020260EZCrownR-EZC-P-A5SL2022-12-01
00819235020277EZCrownR-EZC-P-A62022-12-01
00819235020284EZCrownR-EZC-P-A6SL2022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518341511Any-PasteMEDICLUS CO.,LTDKIF2026-06-01
08809518345106One-Fil Putty InjectableMEDICLUS CO.,LTDKIF2026-05-21
06972902583292C-RootBeijing C-Root Dental Medical Devices Co., LTD.KIF2026-05-15
06972902583308C-RootBeijing C-Root Dental Medical Devices Co., LTD.KIF2026-05-15
08809518341252One-FilMEDICLUS CO.,LTDKIF2026-05-11
08809518343706One-Fil PuttyMEDICLUS CO.,LTDKIF2026-05-11
08404535015126Brasseler USAPeter Brasseler Holdings, LLCKIF2026-04-29
08809518346608CanalPro CalciSealMEDICLUS CO.,LTDKIF2026-04-23
08809262954371VioSealSpident Co., Ltd.KIF2026-04-20
07898078652961BIO-C REPAIR Angelus Industria de Produtos Odontologicos S AKIF2026-03-25
07290115050523BJM Root Canal SealerB.J.M. LABORATORIES LTDKIF2026-03-20
00195062152771ZenSeal ProKerr CorporationKIF2026-02-10
00850440008490Actacal Bioceramic SealerEngineered Endodontics, LLCKIF2026-01-02
08800123819730Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819747Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819754Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459402Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459419Well-Root PTVERICOM CO., LTD.KIF2025-11-27
06976329180256Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180263Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180270Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180287Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180294Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180300Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180317Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180324Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180331Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180348Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180355Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180362Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31