FDA.report

ProMark

Primary DI
D716PMKEM11
Brand
ProMark
Company
TULSA DENTAL PRODUCTS LLC
Model
PMKEM1
Catalog number
PMKEM1
Device description
ProMark Endo Motor
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

Related Records

Product Codes

CodeName
EKXHandpiece, direct drive, ac-powered

Product Code Classifications

CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D716PMKEM11PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental laboratory drilling system motorA mains electricity (AC-powered) engine (motor) used in a dental laboratory in conjunction with a flexible drive system (e.g., a Bowden cable) to provide the rotational power for a dental laboratory handpiece. It is typically combined with different speed controllers. This is a reusable device.

Sterilization Methods

Method
Liquid Chemical

Regulatory Flags

DUNS number
942778564
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
D716PUENDO11ProUltraPUENDO1PUENDO12016-10-07
D716PUENDO151ProUltraPUENDO1-5PUENDO1-52016-11-11
D716PUENDO21ProUltraPUENDO2PUENDO22016-10-07
D716PUENDO31ProUltraPUENDO3PUENDO32016-10-07
D716PUENDO41ProUltraPUENDO4PUENDO42016-10-07
D716PUENDO51ProUltraPUENDO5PUENDO52016-10-07
D716PUENDO61ProUltraPUENDO6PUENDO62016-10-07
D716PUENDO681ProUltraPUENDO6-8PUENDO6-82016-11-11
D716PUENDO71ProUltraPUENDO7PUENDO72016-10-07
D716PUENDO81ProUltraPUENDO8PUENDO82016-10-07
D716PUSINE11ProUltraPUSINE1PUSINE12016-10-07
D716PUSINE161ProUltra SINEPUSINE1-6PUSINE1-62016-11-11
D716PUSINE21ProUltraPUSINE2PUSINE22016-10-07
D716PUSINE31ProUltra SINEPUSINE3PUSINE32016-10-07
D716PUSINE41ProUltra SINEPUSINE4PUSINE42016-10-07
D716PUSINE51ProUltra SINEPUSINE5PUSINE52016-10-07
D716PUSINE61ProUltra SINEPUSINE6PUSINE62016-10-07
D716PUSURG11ProUltraPUSURG1PUSURG12016-10-07
D716PUSURG161ProUltraPUSURG1-6PUSURG1-62016-11-11
D716PUSURG21ProUltraPUSURG2PUSURG22016-10-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800313230000ChecQPEGDENTIS CO. ,LTDEKX2026-03-03
10194665008444A-decA-DEC, INC.EKX2026-02-19
E27668665320Midwest IMPLANT 20:1SIRONA Dental Systems GmbHEKX2026-02-19
09010522002506SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002520SmartPeg Type 137Osstell ABEKX2026-02-09
06941877827809ZarcChangzhou Sifary Medical Technology Co., Ltd.EKX2026-01-05
06944835130195NIC/SUPERLINEShenzhen Superline Technology Co., Ltd.EKX2025-12-22
10817417020395AsepticoASEPTICO, INC.EKX2025-12-16
10817417020401AsepticoASEPTICO, INC.EKX2025-12-16
08056814270117EnDrive ADVANCED TECHNOLOGY RESEARCH A.T.R. SRLEKX2025-11-26
09010522002650Osstell Beacon InstrumentOsstell ABEKX2025-09-26
09010522002667MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518327InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
08809455602683elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602720elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602744elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08800053084123ChecQDENTIS CO. ,LTDEKX2025-03-31
08800053092494ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092500ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092517ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092524ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092531ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092548ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092555ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092562ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092579ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092586ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092593ChecQPEG DriverDENTIS CO. ,LTDEKX2025-03-31
08800266943897ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
09010522002551Osstell SmartPeg Type 112Osstell ABEKX2025-03-27