FDA.reportPublic FDA data

MAARC DENTAL-Calcium Hydroxide Powder

Primary DI
08906110440397
Brand
MAARC DENTAL-Calcium Hydroxide Powder
Company
SHIVA PRODUCTS
Model
5002/100B
Catalog number
5002/100B
Device description
Calcium hydroxide is used as an agent to induce apexification in pediatric endodontics. The product may also be used as a pulp capping material and as a base under nonadhesive restorations.
Published
2024-10-02
Public version status
New
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
08906110440397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906110440397089061104403978906110440397

GMDN Terms#

Term, Definition table
TermDefinition
Calcium hydroxide dental cementA non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. 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
08906110440403MAARC DENTAL-Calx-O9102/1.5x29102/1.5x22024-10-02
08906110440007MAARC DENTAL-Sealmax - R8001/0018001/0012024-10-02
08906110440175Maarc dental - Articulating Paper5521/0015521/0012024-10-02
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
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06976329180362Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
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