FDA.reportPublic FDA data

Calamus

Primary DI
D716CALSTOP0
Brand
Calamus
Company
TULSA DENTAL PRODUCTS LLC
Model
CALSTOP
Catalog number
CALSTOP
Device description
CALAMUS PLUGGER: Rubber Stoppers-100
Published
2022-10-18
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
false

Product Codes#

Code, Name table
CodeName
EKRPLUGGER, ROOT CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D716CALSTOP1PrimaryHIBCC0
D716CALSTOP0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Warm-bonded endodontic obturation systemAn assembly of devices designed to deliver preheated resin-based sealing, filling, and core materials into a root canal for direct warm bonding during an endodontic obturation procedure. It typically consists of a mains electricity (AC-powered) oven used to heat the preloaded oburators, a series of root canal sizers (verifiers) used for the selection of the appropriate obturator, and preloaded obturators; other materials may be included (e.g., self-etch sealer).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
942778564
Device count
100
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D716GTPOSTFSAM1GT Post and DrillsGTPOSTFSAMGTPOSTFSAM2022-09-01
D716BP156L1BioPureBPSYRNDL2BP156L2022-10-13
D716BP156P1BioPureBPSYRNDL2BP156P2022-10-13
D716BP156SYS1BioPureBPSYRNDL2BP156SYS2022-10-13
D716BP288P1BioPureBPSYRNDL2BP288P2022-10-13
D716BP36L1BioPureBPSYRNDL2BP36L2022-10-13
D716BP36P1BioPureBPSYRNDL2BP36P2022-10-13
D716BP36SYS1BioPureBPSYRNDL2BP36SYS2022-10-13
D716BP48L1BioPureBPSYRNDL2BP48L2022-10-13
D716BP48P1BioPureBPSYRNDL2BP48P2022-10-13
D716BP48R1BioPureBPSYRNDL2BP48R2022-10-13
D716BPSYRNDL21BioPureBPSYRNDL2BPSYRNDL22022-10-13
D716PIEZOFLOWREFILL1ProUltra PiezoFlowPIEZOFLOWREFILLPIEZOFLOWREFILL2022-10-18
D716PUENDO11ProUltraPUENDO1PUENDO12016-10-07
D716PUENDO151ProUltraPUENDO1-5PUENDO1-52016-11-11
D716PUENDO21ProUltraPUENDO2PUENDO22016-10-07
D716PUENDO31ProUltraPUENDO3PUENDO32016-10-07
D716PUENDO41ProUltraPUENDO4PUENDO42016-10-07
D716PUENDO51ProUltraPUENDO5PUENDO52016-10-07
D716PUENDO61ProUltraPUENDO6PUENDO62016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810137JAS Heat Plugger TipDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810168JAS Pack Gutta-Percha CutterDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKR2026-09-24
G8791062850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
G8791062880DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
08404535018981Brasseler USAPeter Brasseler Holdings, LLCEKR2026-06-26
00348783009002Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009019Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009026Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009033Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009057Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783008975Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008982Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008999Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009125Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009132Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009149Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008913Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008920Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008937Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008944Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28