FDA.report

Johnson-Promident

Primary DI
10840326416751
Brand
Johnson-Promident
Company
Young Innovations, Inc.
Model
4-1EPBEND-ASSY
Catalog number
4-1EPBEND-ASSY
Device description
4:1 1/4 TURN PUSH BUTTON HAND FILE ENDO CONTRA ANGLE
Published
2022-11-24
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
EFBHandpiece, air-powered, dental

Product Code Classifications

CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840326416751PackageGS11In Commercial Distribution
00840326416754PrimaryGS10

GMDN Terms

TermDefinition
Dental power tool handpiece motorless componentA component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (800) 210-8945customerservice@younginnovations.com

Regulatory Flags

DUNS number
004193103
Device count
1
DM exempt
true
Premarket exempt
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10840326426200Young Specialties2000-02-102000-02-102026-01-26
10840326426217Young Specialties2000-03-102000-03-102026-01-26
10840326426224Young Specialties2000-04-102000-04-102026-01-26
10840326426231Young Specialties2000-05-102000-05-102026-01-26
10840326426248Young Specialties2000-06-102000-06-102026-01-26
10840326426255Young Specialties2000-07-102000-07-102026-01-26
10840326426262Young Specialties2000-08-102000-08-102026-01-26
10840326426279Young Specialties2000-09-102000-09-102026-01-26
10840326426286Young Specialties2000-10-102000-10-102026-01-26
10840326426293Young Specialties2000-15-102000-15-102026-01-26
00840326426302Young Specialties2000-16-102000-16-102026-01-26
10840326426316Young Specialties2000-17-102000-17-102026-01-26
10840326426323Young Specialties2000-18-102000-18-102026-01-26
10840326426330Young Specialties2000-19-102000-19-102026-01-26
10840326426347Young Specialties2000-20-102000-20-102026-01-26
10840326426354Young Specialties2000-21-102000-21-102026-01-26
10840326426361Young Specialties2000-22-102000-22-102026-01-26
10840326426378Young Specialties2000-23-102000-23-102026-01-26
10840326426385Young Specialties2000-24-102000-24-102026-01-26
10840326426392Young Specialties2000-25-102000-25-102026-01-26

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008171690239203D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFB2026-03-11
008171690239373D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFB2026-03-11
00817169028017Hydrolux by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFB2026-03-11
J00716014030011PM OSCILLATING IPRBien-Air Dental SAEFB2026-01-23
03609820101286BUSE PERIO MAINT AIR N GO EASYSATELECEFB2025-12-10
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J021020835000MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J021063951001MCA-QC-RMW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J021064226001MCA-QC-ISOW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600677001USA1MOT MX2BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2025-10-13
J0071600755001USA1MOT MX-i LEDBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2025-10-13
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