FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF24751296OX0
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
24.751.296OX
Catalog number
24.751.296OX
Device description
CURETTE INSERT, M4X0,5, FOR BIONIK-HANDLE, CM7 MOLT FIG.5, 7MM ONYX-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
EMKCURETTE, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF24751296OX0PrimaryHIBCC0

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
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
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B382SD914631720Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631770Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631780Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631790Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914638200Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914638210Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD9146461000Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD9146531550Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD902511300Surgical DirectSurgical Direct, Inc.EMK2026-07-24
B382SD9143681000Surgical DirectSurgical Direct, Inc.EMK2026-07-13
00850083275532Intrace USAPILOTIS TECH LLCEMK2026-07-03
00841336106413Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2026-06-08
G149TBSB7900TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7910TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7920TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7930TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7940TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7950TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149NP380620NPSACME ENTERPRISE.EMK2026-05-01
G149NPSCL0NPSACME ENTERPRISE.EMK2026-05-01
10889950126339Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06