FDA.reportPublic FDA data

Komet BioSeal Starter Kit 2.2 g

Primary DI
00850008515231
Brand
Komet BioSeal Starter Kit 2.2 g
Company
NUSMILE, LTD.
Model
KBCS1
Device description
For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
Published
2020-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850008515231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008515231008500085152318500085152310850008515231

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic filling/sealing materialA prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include, but are not limited to, silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). This GMDN code does not include gutta-percha. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight2.2Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature72 Degrees Fahrenheit0 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
185497372
Device count
1
DM exempt
true
Kit
true
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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00810118107979NuSmile Heavy Band PusherBP-0022026-04-08
00810118107986NuSmile 3 Jaw PlierTJP-0032026-04-08
00810118107993NuSmile Bird Beak PlierBBP-0042026-04-08
00810118108006NuSmile Band / Crown Crimping PlierBCP-0052026-04-08
00810118108013NuSmile Heavy Curved ScissorsHCS-0062026-04-08
00810118108020NuSmile Posterior Band RemoverPBR-0072026-04-08
00810118108037NuSmile Tube Crimping PlierTCP-0082026-04-08
00810118108044NuSmile Contouring PlierCP-0092026-04-08
00810118108051NuSmile Hard Wire CutterHWC-0102026-04-08
00810118107948NuSmile NuCemNCRSKI2026-04-08
00810118107955NuSmile NuCemNCRPKI2026-04-08
00810118108068Zarc by Avalon Biomed NanoShaper Gutta-Percha Assorted ZN1-ZN5 (Sample)SGP-N1992026-04-06
00810118107931NuSmile NuCemNCRPK2026-04-02
00810118107924NuSmile NuCemNCRSK2026-04-01
00810118103650Zarc by Avalon Biomed Gutta Perch Obturator (Pellets)63440032026-01-15
00810118105555Ultradent MTApex 5.0 g Powder138692026-01-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809518341252One-FilMEDICLUS CO.,LTDKIF2026-05-11
08809518343706One-Fil PuttyMEDICLUS CO.,LTDKIF2026-05-11
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