FDA.reportPublic FDA data

EdgeBioCeramic™

Primary DI
00818365026760
Brand
EdgeBioCeramic™
Company
US ENDODONTICS, LLC
Model
EEBCT15
Catalog number
EEBCT15
Device description
EdgeBioCeramic™ Tips NeoPRO™ Bioceramic Sealer
Published
2023-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
00818365026760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365026760008183650267608183650267600818365026760

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(423)283-0047Bobby.bennett@us-endo.com

Regulatory Flags#

DUNS number
061317427
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810047645358EdgeSequel UtopiaES150421SEES150421SE2023-07-28
10810047645365EdgeSequel UtopiaES150425SEES150425SE2023-07-28
10810047645372EdgeSequel UtopiaES150431SEES150431SE2023-07-28
10810047645389EdgeSequel UtopiaES250421SEES250421SE2023-07-28
10810047645396EdgeSequel UtopiaES250425SEES250425SE2023-07-28
10810047645402EdgeSequel UtopiaES250431SEES250431SE2023-07-28
10810047645419EdgeSequel UtopiaES300421SEES300421SE2023-07-28
10810047645426EdgeSequel UtopiaES300425SEES300425SE2023-07-28
10810047645433EdgeSequel UtopiaES300431SEES300431SE2023-07-28
10810047645440EdgeSequel UtopiaES400421SEES400421SE2023-07-28
10810047645457EdgeSequel UtopiaES400425SEES400425SE2023-07-28
10810047645464EdgeSequel UtopiaES400431SEES400431SE2023-07-28
10810047645471EdgeSequel UtopiaES500421SEES500421SE2023-07-28
10810047645488EdgeSequel UtopiaES500425SEES500425SE2023-07-28
10810047645495EdgeSequel UtopiaES500431SEES500431SE2023-07-28
10810047645501EdgeSequel UtopiaES250621SEES250621SE2023-07-28
10810047645518EdgeSequel UtopiaES250625SEES250625SE2023-07-28
10810047645525EdgeSequel UtopiaES250631SEES250631SE2023-07-28
10810047645532EdgeSequel UtopiaES300621SEES300621SE2023-07-28
10810047645549EdgeSequel UtopiaES300625SEES300625SE2023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
E22116451MTA vptVOCO GmbHKIF2025-07-07
06976329180379Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
06976329180386Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
06976329180393Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
06976329180409Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
06976329180416Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
D01060620110NA1AH Plus Endodontic Sealer TubesDentsply De Trey GmbHKIF2025-03-31
D01060620115NA1AH Plus Jet Endodontic Sealer Starter KitDentsply De Trey GmbHKIF2025-03-31
D01060620118NA0AH Plus Jet Endodontic Sealer Syringe RefillDentsply De Trey GmbHKIF2025-03-31
07898078659465PURE-Ca-SEAL Angelus Industria de Produtos Odontologicos S AKIF2025-03-20
00883205039187UltraCal XSULTRADENT PRODUCTS, INC.KIF2025-03-11
D690220102SSW ENDOSs White Burs, Inc.KIF2025-02-19
D690220110SSW ENDOSs White Burs, Inc.KIF2025-02-19
D690220122SSW ENDOSs White Burs, Inc.KIF2025-02-19
07898078659939Komet BioRepairAngelus Industria de Produtos Odontologicos S AKIF2024-11-26
10818207024913RE-GEN Bioactive EndoPutty KitVista DentalKIF2024-11-14
00766054002949BIOSEALESSENTIAL DENTAL SYSTEMS, INC.KIF2024-10-31
TQ26126092991Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.KIF2024-10-31
10810138823238EndoCeramic Root Repair MaterialEndo Direct LLCKIF2024-10-21
08404535006025BC Sealer Ion+ Angelus Industria de Produtos Odontologicos S AKIF2024-10-15
08404535006414BC Sealer Ion+ Angelus Industria de Produtos Odontologicos S AKIF2024-10-15
08404535006445BC Sealer Ion+Angelus Industria de Produtos Odontologicos S AKIF2024-10-15