FDA.reportPublic FDA data

Calamus

Primary DI
D716PACKHAND1
Brand
Calamus
Company
TULSA DENTAL PRODUCTS LLC
Model
PACKHAND
Catalog number
PACKHAND
Device description
Pack Handpiece For Dual
Published
2022-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKMGUTTA-PERCHA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D716PACKHAND1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental laboratory drilling system handpieceA hand-held device that includes a chuck for attaching drills, burs, grind wheels, and similar rotating devices used in the dental laboratory. The device is typically remote from the power source (e.g., a dental laboratory drill motor) and is connected to this by a flexible drive system, which may be a Bowden cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
942778564
Device count
1
Premarket exempt
true
Lot or batch
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
10817417020197Dentsply SironaASEPTICO, INC.EKM2026-09-28
06979865810120JAS Gutta-Percha PelletsDENJOY DENTAL CO.,LTDEKM2026-09-24
J0030525020Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525025Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525030Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525035Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525040Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525045Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525050Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525055Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525060Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525160Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525165Z1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530F1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FFZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FM1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FMZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530L1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530M1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MFZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530XF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530XFM1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FL1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FM1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FS1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541L1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26