FDA.reportPublic FDA data

Actacal Bioceramic Sealer

Primary DI
00850440008490
Brand
Actacal Bioceramic Sealer
Company
Engineered Endodontics, LLC
Model
ACS
Device description
Dental Sealer
Published
2026-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850440008490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850440008490008504400084908504400084900850440008490

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
079892178
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
00850440008001TUN Ultrasonic TipE12026-01-02
00850440008025TUN Ultrasonic TipE22026-01-02
00850440008049TUN Ultrasonic TipE32026-01-02
00850440008063TUN Ultrasonic TipE42026-01-02
00850440008087TUN Ultrasonic TipE52026-01-02
00850440008100TUN Ultrasonic TipE62026-01-02
00850440008124Finishing File2004212026-01-02
00850440008131Finishing File2004252026-01-02
00850440008148Finishing File2004312026-01-02
00850440008254TUN Ultrasonic TipR12026-01-02
00850440008278TUN Ultrasonic TipR22026-01-02
00850440008292TUN Ultrasonic TipR32026-01-02
00850440008339IrriGatorESIT30222026-01-02
00850440008346IrriGatorESIT30262026-01-02
00850440008353IrriGatorESITPR272026-01-02
00850440008360IrriGatorESITPR302026-01-02
00850440008377IrriGatorESITPL272026-01-02
00850440008384IrriGatorESITPL302026-01-02
00850440008391ES Cap TipsESCAP2026-01-02
00850440008407EDTAESEDTA2026-01-02

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
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