FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF2499055OX0
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
24.990.55OX
Catalog number
24.990.55OX
Device description
CURETTE PERIO, BIONIK PROHPYLAXIS SET M5 NANOPAL ALL INSTRUMENTS WITH NANOPAL-COATING
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
EZPF2499055OX0PrimaryHIBCC0

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275648Intrace USAPILOTIS TECH LLCEMS2026-07-03
08404535019018Brasseler USAPeter Brasseler Holdings, LLCEMS2026-06-26
G149TBSB5050TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5060TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5070TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5080TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5100TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5120TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5130TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5140TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5160TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5170TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5180TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5200TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5210TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5220TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5230TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5240TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5250TBS BASICSACME ENTERPRISE.EMS2026-05-20
EZPF2423001G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423001GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423103G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105L0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423411G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423411GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423415G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423507G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423507GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13