FDA.reportPublic FDA data

MAARC DENTAL-Calx-O

Primary DI
08906110440403
Brand
MAARC DENTAL-Calx-O
Company
SHIVA PRODUCTS
Model
9102/1.5x2
Catalog number
9102/1.5x2
Device description
It is a water based white paste consisting of premixed Calcium Hydroxide and Barium Sulphate. Supplied in a multi dose syringe with disposable pre-bent cannulas for dispensing.
Published
2024-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K240446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240446000Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +Shiva Products2024-07-30KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906110440403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906110440403089061104404038906110440403

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic temporary cementA viscous material intended to be applied to a prepared root canal to maintain its relative sterility between procedures and to facilitate its healing. It is intended to be placed within the root canal temporarily and sealed with a temporary filling material to prevent repopulation of the canal by bacteria. It is typically a zinc or calcium cement-based material that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a tube or syringe. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
737988276
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906110440014MAARC DENTAL-Calahyd-RC9103/15x29103/15x22024-10-02
08906110440007MAARC DENTAL-Sealmax - R8001/0018001/0012024-10-02
08906110440175Maarc dental - Articulating Paper5521/0015521/0012024-10-02
08906110440397MAARC DENTAL-Calcium Hydroxide Powder5002/100B5002/100B2024-10-02
08906110440458MAARC DENTAL - Ceraseal-B8501/0018501/0012024-10-02
08906110443039MAARC DENTAL -Rootfyx9107/0.5x49107/0.5x42024-10-02
08906110443053MAARC DENTAL - Sealmax + 8011/0018011/0012024-10-02
08906110443060MAARC DENTAL-Sealmax + 8011/0028011/0022024-10-02
08906110443145MAARC DENTAL-MTA Fast set kit8601/0018601/0012024-10-02
08906110443152MAARC DENTAL-MTA Fast set (unidose kit)8601/0028601/0022024-10-02
08906110443619MAARC DENTAL-Calcium Hydroxide Powder (with Barium Sulphate) 5002/015B5002/015B2024-10-02
08906110443732MAARC DENTAL - MTA Fast Set8601/0.58601/0.52024-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
E22116461MTA vptVOCO GmbHKIF2025-10-14