FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF19125000
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
19.125.00
Catalog number
19.125.00
Device description
FOR RUBBER DAM FORCEPS - FRAME ONLY SIZE M, APPROX. 10 X 9.5 CM
Published
2022-11-29
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
EJGFORCEPS, RUBBER DAM CLAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF19125000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam frameA flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. 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
G8791032710DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032720DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G149TBSB2110TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2120TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2130TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2150TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2160TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2170TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2180TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2190TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2200TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2210TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2220TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2230TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2240TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2250TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2260TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2270TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2280TBS BASICSACME ENTERPRISE.EJG2026-05-16
00371347023534Advance Dental ProductsThe Atlanta Dental Supply CompanyEJG2026-04-14
00371347023541Advance Dental ProductsThe Atlanta Dental Supply CompanyEJG2026-04-14
00371347023558Advance Dental ProductsThe Atlanta Dental Supply CompanyEJG2026-04-14
08800019151012BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151029BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151036BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151043BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151050BL Clamp B& L Biotech, inc.EJG2025-07-18