FDA.reportPublic FDA data

SCHWERT

Primary DI
E896330111M5TI0
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
3301-11M5TI
Catalog number
3301-11M5TI
Device description
Special curette, Gracey, GRA 11/12 M5, Schwert Color-Code handle, purple, exchangable titanium tips, 17.5cm,
Published
2023-02-22
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
EMSCURETTE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E896330111M5TI0PrimaryHIBCC0

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
+49746498910700contact@schwert.com

Regulatory Flags#

DUNS number
341195628
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
E8961411020SCHWERT1411-021411-022026-05-21
E8961411050SCHWERT1411-051411-052026-05-21
E896143650SCHWERT1436-51436-52026-04-16
E8961125400B0SCHWERT1125-400B1125-400B2026-03-18
E89628870SCHWERT288728872025-12-16
E8961490500SCHWERT1490-501490-502025-11-27
E8961145610SCHWERT11456-111456-12025-10-15
E89616970207E0SCHWERT1697-02-07E1697-02-07E2025-10-14
E89616970307E0SCHWERT1697-03-07E1697-03-07E2025-10-14
E89616970TI07E0SCHWERT1697-0TI-07E1697-0TI-07E2025-10-14
E8961705207E0SCHWERT1705-2-07E1705-2-07E2025-10-14
E8961705307E0SCHWERT1705-3-07E1705-3-07E2025-10-14
E8961705607E0SCHWERT1705-6-07E1705-6-07E2025-10-14
E89617057507E0SCHWERT1705-75-07E1705-75-07E2025-10-14
E896193950SCHWERT19395193952025-10-14
E89617059007E0SCHWERT1705-90-07E1705-90-07E2025-09-04
E89617059101E0SCHWERT1705-91-01E1705-91-01E2025-09-04
E89617059206E0SCHWERT1705-92-06E1705-92-06E2025-09-04
E89617059303E0SCHWERT1705-93-03E1705-93-03E2025-09-04
E896169701TI07E0SCHWERT1697-01TI-07E1697-01TI-07E2025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879102188H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102198H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102207H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102208H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102209H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102210H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102214H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102215H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102216H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC15160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC17180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14