FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF08917000
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
08.917.00
Catalog number
08.917.00
Device description
DEPTH GAUGE;FLAG HOLDER SET F.EASY CHECKOF PARALLELISM OF IMPLANT DRILL HOLES, 5MM/7MM/13M/20MM IN BUR STAND
Published
2022-11-25
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
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF08917000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. 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
Kit
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB1270TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4230TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
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J003PTGSVF21Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF31Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF41Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF51Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVAST1Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX21Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX31Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX41Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX51Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVAST1Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVF11Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26