FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF26388010
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
26.388.01
Catalog number
26.388.01
Device description
CONDENSER, AMALGAM F. AMALGAM, GUTTAPERCHA & CEMENT, SMOOTH FIG. 1, WARD
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF26388010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49742498880info@zepf-dental.com

Regulatory Flags#

DUNS number
320001431
Device count
1
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EZPF2305412HZU0HELMUT ZEPF23.054.12HZU23.054.12HZU2025-03-10
EZPF33750010HELMUT ZEPF33.750.0133.750.012025-03-10
EZPF3375001F0HELMUT ZEPF33.750.01F33.750.01F2025-03-10
EZPF33750020HELMUT ZEPF33.750.0233.750.022025-03-10
EZPF33760020HELMUT ZEPF33.760.0233.760.022025-03-10
EZPF33760030HELMUT ZEPF33.760.0333.760.032025-03-10
EZPF33760110HELMUT ZEPF33.760.1133.760.112025-03-10
EZPF33760200HELMUT ZEPF33.760.2033.760.202025-03-10
EZPF33760210HELMUT ZEPF33.760.2133.760.212025-03-10
EZPF1704503HZU0HELMUT ZEPF17.045.03HZU17.045.03HZU2025-03-07
EZPF1742301HZU0HELMUT ZEPF17.423.01HZU17.423.01HZU2025-03-07
EZPF1742302HZU0HELMUT ZEPF17.423.02HZU17.423.02HZU2025-03-07
EZPF2474403LM5HZU0HELMUT ZEPF24.744.03LM5-HZU24.744.03LM5-HZU2025-03-07
EZPF2474405GHZU0HELMUT ZEPF24.744.05G-HZU24.744.05G-HZU2025-03-07
EZPF2474408HZU0HELMUT ZEPF24.744.08HZU24.744.08HZU2025-03-07
EZPF2474411GHZU0HELMUT ZEPF24.744.11G-HZU24.744.11G-HZU2025-03-07
EZPF2474413GHZU0HELMUT ZEPF24.744.13G-HZU24.744.13G-HZU2025-03-07
EZPF2474455HZU0HELMUT ZEPF24.744.55HZU24.744.55HZU2025-03-07
EZPF2474460HZU0HELMUT ZEPF24.744.60HZU24.744.60HZU2025-03-07
EZPF2474465HZU0HELMUT ZEPF24.744.65HZU24.744.65HZU2025-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018672307Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-11
00840018670365Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018671867Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018671904Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018666092Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-09
00840018662506Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018663275Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018661325Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661387Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661769Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661936Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
05010058178106InstrapacROBINSON HEALTHCARE LIMITEDEKG2025-06-23
00889813065976Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-12-12
00889813065952Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065969Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065983Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065990Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066003Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066027Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066034Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066010Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-10-01
00842517118553Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118560Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118577Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118584Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118591Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
08800075604668OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075604675OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609670OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609717OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04