FDA.report

HELMUT ZEPF

Primary DI
EZPFKS265140
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
KS26.514
Catalog number
KS26.514
Device description
BURNISHER, OPERATIVE BURNISHER, FIG.514 AS P.SAMPLE, D/E, 10RINGS, SATIN FINISH
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

Related Records

Contact Domains

Product Codes

CodeName
EKJBURNISHER, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EZPFKS265140PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
00348783009361Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-03-17
00840018667389Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018671508Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018672314Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018665729Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018666139Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018662247Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
00840018662896Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
05010058178090InstrapacROBINSON HEALTHCARE LIMITEDEKJ2025-06-23
00889813065884Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065891Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065907Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065914Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065921Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065945Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813066157Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065938Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-10-01
00813677025159PDT, Inc.PDT, INC.EKJ2024-09-11
00813677025166PDT, Inc.PDT, INC.EKJ2024-09-11
00842517118652Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118669Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118676Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
08800075604774OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-03-04
08800075604750OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08800075604767OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08800075624000OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08964003163297NivoB. Ali ImpexEKJ2024-01-27
08964003163303NivoB. Ali ImpexEKJ2024-01-27
10889950112929Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKJ2023-07-19
10889950114046Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKJ2023-06-27