FDA.report

SSW ENDO

Primary DI
D690220122
Brand
SSW ENDO
Company
Ss White Burs, Inc.
Model
NONE
Catalog number
22012
Device description
PURE-Ca-SEAL Endodontic Bioceramic Sealer
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KIFRESIN, ROOT CANAL FILLING

Product Code Classifications

CodeDeviceSpecialtyClass
KIFResin, Root Canal FillingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D690220122PrimaryHIBCC0

GMDN Terms

TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(732)905-1100customerservice@sswhitedental.com

Regulatory Flags

DUNS number
151760014
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
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
D6903100450SSW CARBIDEHP-PBUR-1/43100452026-02-16
D6903100470SSW CARBIDEHP-PBUR-13100472026-02-16
D6903100480SSW CARBIDEHP-PBUR-23100482026-02-16
D6903100490SSW CARBIDEHP-PBUR-33100492026-02-16
D6903100500SSW CARBIDEHP-PBUR-43100502026-02-16
D6903100510SSW CARBIDEHP-PBUR-53100512026-02-16
D6903100520SSW CARBIDEHP-PBUR-63100522026-02-16
D6903100530SSW CARBIDEHP-PBUR-73100532026-02-16
D6903100540SSW CARBIDEHP-PBUR-83100542026-02-16
D6903100550SSW CARBIDEHP-PBUR-SC103100552026-02-16
D6903100570SSW CARBIDEHP-PBUR-33-1/23100572026-02-16
D6903100610SSW CARBIDEHP-PBUR-373100612026-02-16
D6903100670SSW CARBIDEHP-PBUR-5583100672026-02-16
D6903100720SSW CARBIDEHP-PBUR-6993100722026-02-16
D6903100730SSW CARBIDEHP-PBUR-7003100732026-02-16
D6903100740SSW CARBIDEHP-PBUR-7013100742026-02-16
D6903100750SSW CARBIDEHP-PBUR-7023100752026-02-16
D6903100770SSW CARBIDEHP-PBUR-7033100772026-02-16
D6903100930SSW CARBIDEFG-PBUR-1/23100932026-02-16
D6903100950SSW CARBIDEFG-PBUR-13100952026-02-16

Other Devices Sharing Product Codes

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
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
07898078651605PURE-Ca-SEALAngelus Industria de Produtos Odontologicos S AKIF2024-10-14