FDA.report

SCHWERT

Primary DI
E896307550
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
3075-5
Catalog number
3075-5
Device description
Explorers round handle 17cm UNIVERSAL
Published
2023-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EKBEXPLORER, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E896307550PrimaryHIBCC0

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
+49746498910700contact@schwert.com

Regulatory Flags

DUNS number
341195628
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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E8961411040SCHWERT1411-041411-042025-04-07
E8961411060SCHWERT1411-061411-062025-04-07
E896169710007E0SCHWERT1697-100-07E1697-100-07E2025-04-07
E89616971TI06E0SCHWERT1697-1TI-06E1697-1TI-06E2025-04-07
E896170512007E0SCHWERT1705-120-07E1705-120-07E2025-04-07

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00348783005974Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
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00348783006018Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006056Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006063Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
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00840018664012Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-04
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EZPF2474460HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
EZPF2474465HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
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