FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF2423804SD0
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
24.238.04SD
Catalog number
24.238.04SD
Device description
SICKLE SCALER PERIODONTIC, FIG.204SD ZEPF-LOTUS HANDLE, COLOR CODING GREEN INSERTS INTERCHANGEABLE
Published
2026-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMNSCALER, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF2423804SD0PrimaryHIBCC0

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
EZPF2423806HF0HELMUT ZEPF24.238.06HF24.238.06HF2026-04-13
EZPF2423823A0HELMUT ZEPF24.238.23A24.238.23A2026-04-13
EZPF2423901L0HELMUT ZEPF24.239.01L24.239.01L2026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456224861JMUJMU DENTAL, INCEMN2026-09-30
00840456224878JMUJMU DENTAL, INCEMN2026-09-30
00840456224885JMUJMU DENTAL, INCEMN2026-09-30
00840456224892JMUJMU DENTAL, INCEMN2026-09-30
00840456224908JMUJMU DENTAL, INCEMN2026-09-30
00840456224915JMUJMU DENTAL, INCEMN2026-09-30
06973042242995Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243008Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
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06973042243022Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243039Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
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06973042243053Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
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06973042243077Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
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06973042243121Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243138Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243145Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243152Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243169Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243176Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243183Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243190Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243206Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243213Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243220Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30