FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF24751520W0
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
24.751.520W
Catalog number
24.751.520W
Device description
PAPILLA ELEVATOR M4 X 0.5 BY WENG
Published
2022-12-05
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
EMSCURETTE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF24751520W0PrimaryHIBCC0

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
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G879102208H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102209H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102210H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102214H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102215H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102216H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
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G879GC15160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC17180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14