FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF46040070
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
46.040.07
Catalog number
46.040.07
Device description
KNIFE, PERIODONTIC, FIG.1 DOUBLE-ENDED, STRAIGHT/BENDED BIONIK HANDLE BLACK
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
EMOKNIFE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMOKnife, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF46040070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
00840018674011Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-11
00840018666009Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-09
00840018663367Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-04
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLEW.H. Holden, Inc.EMO2026-01-14
D9284001040D9284001040W.H. Holden, Inc.EMO2026-01-14
00841013121050Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121067Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121074Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121128Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121135Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121142Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121159Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
D9284005451HF0VESTIBULAR TUNNELING ELEVATOR #1 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005452HF0VESTIBULAR TUNNELING ELEVATOR #2 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005453HF0VESTIBULAR TUNNELING ELEVATOR #3 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005454HF0VESTIBULAR TUNNELING ELEVATOR #4 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005455HF0VESTIBULAR TUNNELING ELEVATOR #5 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005456HF0VESTIBULAR TUNNELING ELEVATOR #6 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
00840105223757ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223764ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223771ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223788ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223795ZOLL DENTALZoll-DentalEMO2025-08-06
D928400531HFDLC0PA TUNNELING INSTRUMENT #2 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400532HFDLC0PA TUNNELING INSTRUMENT #3 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400533HFDLC0PA TUNNELING INSTRUMENT #4 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400110HF0PERIO KNIFE, TOWNER 19/20, HFW.H. Holden, Inc.EMO2025-02-06