FDA.report

HELMUT ZEPF

Primary DI
EZPFKS242040
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
KS24.204
Catalog number
KS24.204
Device description
SCALER, PERIODONTIC SCALER, No. 204 G, D/E, HANDLE SATIN FINISH WITH 10 RINGS,
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EMNSCALER, PERIODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EZPFKS242040PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+49742498880info@zepf-dental.com

Regulatory Flags

DUNS number
320001431
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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EZPF3375001F0HELMUT ZEPF33.750.01F33.750.01F2025-03-10
EZPF33750020HELMUT ZEPF33.750.0233.750.022025-03-10
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EZPF33760200HELMUT ZEPF33.760.2033.760.202025-03-10
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EZPF1704503HZU0HELMUT ZEPF17.045.03HZU17.045.03HZU2025-03-07
EZPF1742301HZU0HELMUT ZEPF17.423.01HZU17.423.01HZU2025-03-07
EZPF1742302HZU0HELMUT ZEPF17.423.02HZU17.423.02HZU2025-03-07
EZPF2474403LM5HZU0HELMUT ZEPF24.744.03LM5-HZU24.744.03LM5-HZU2025-03-07
EZPF2474405GHZU0HELMUT ZEPF24.744.05G-HZU24.744.05G-HZU2025-03-07
EZPF2474408HZU0HELMUT ZEPF24.744.08HZU24.744.08HZU2025-03-07
EZPF2474411GHZU0HELMUT ZEPF24.744.11G-HZU24.744.11G-HZU2025-03-07
EZPF2474413GHZU0HELMUT ZEPF24.744.13G-HZU24.744.13G-HZU2025-03-07
EZPF2474455HZU0HELMUT ZEPF24.744.55HZU24.744.55HZU2025-03-07
EZPF2474460HZU0HELMUT ZEPF24.744.60HZU24.744.60HZU2025-03-07
EZPF2474465HZU0HELMUT ZEPF24.744.65HZU24.744.65HZU2025-03-07

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