FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF41881010
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
41.881.01
Catalog number
41.881.01
Device description
FILE, BONE MILLER, ALVEOLOTOMY FILE, FIG. 1
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMIFILE, BONE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMIFile, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF41881010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. 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
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EZPF2423001G0HELMUT ZEPF24.230.01G24.230.01G2026-04-13
EZPF2423001GM50HELMUT ZEPF24.230.01GM524.230.01GM52026-04-13
EZPF2423103G0HELMUT ZEPF24.231.03G24.231.03G2026-04-13
EZPF2423105G0HELMUT ZEPF24.231.05G24.231.05G2026-04-13
EZPF2423105GM50HELMUT ZEPF24.231.05GM524.231.05GM52026-04-13
EZPF2423105L0HELMUT ZEPF24.231.05L24.231.05L2026-04-13
EZPF2423411G0HELMUT ZEPF24.234.11G24.234.11G2026-04-13
EZPF2423411GM50HELMUT ZEPF24.234.11GM524.234.11GM52026-04-13
EZPF2423415G0HELMUT ZEPF24.234.15G24.234.15G2026-04-13
EZPF2423507G0HELMUT ZEPF24.235.07G24.235.07G2026-04-13
EZPF2423507GM50HELMUT ZEPF24.235.07GM524.235.07GM52026-04-13
EZPF2423609G0HELMUT ZEPF24.236.09G24.236.09G2026-04-13
EZPF2423713G0HELMUT ZEPF24.237.13G24.237.13G2026-04-13
EZPF2423713GM50HELMUT ZEPF24.237.13GM524.237.13GM52026-04-13
EZPF2423717G0HELMUT ZEPF24.237.17G24.237.17G2026-04-13
EZPF2423803L0HELMUT ZEPF24.238.03L24.238.03L2026-04-13
EZPF2423804S0HELMUT ZEPF24.238.04S24.238.04S2026-04-13
EZPF2423804SD0HELMUT ZEPF24.238.04SD24.238.04SD2026-04-13
EZPF2423806HF0HELMUT ZEPF24.238.06HF24.238.06HF2026-04-13
EZPF2423823A0HELMUT ZEPF24.238.23A24.238.23A2026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783010053Premier FilePREMIER DENTAL PRODUCTS COMPANYEMI2026-04-27
00840018672642Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-11
00840018663589Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018665514Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018662476Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018662858Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018663220Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00194613115968MSI Precision Specialty InstrumentsMed Saver, Inc.EMI2025-08-01
00190776405229MillenniumAvalign Technologies, Inc.EMI2025-07-14
00889813066874Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00889813066881Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00840306823619Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EMI2025-01-17
00840306823626Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EMI2025-01-17
00813677025135PDT, Inc.PDT, INC.EMI2024-08-12
06974456210761CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
86974456210767CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
00813677024558PDT, Inc.PDT, INC.EMI2024-07-03
00813677024497PDT, Inc.PDT, INC.EMI2024-06-27
00190776388911AvalignAvalign Technologies, Inc.EMI2024-05-15
00842517105638Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00842517105645Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00888515225336BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225374BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225497BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
08800075612892OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27
08800075612908OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27
08800075612878OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-19
D955BFS3201Paul BandittTerlain Enterprises, Inc.EMI2023-12-11
D955BFX1101Paul BandittTerlain Enterprises, Inc.EMI2023-12-11
D955BFX12C1Paul BandittTerlain Enterprises, Inc.EMI2023-12-11