FDA.reportPublic FDA data

SCHWERT

Primary DI
E8961705550
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
1705-55
Catalog number
1705-55
Device description
Periodontic knife, Orban 1/2, 17,5cm modified, double-ended, exchangable tipsSWORD DESIGN handle, 2,5mm
Published
2023-02-20
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
E8961705550PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
SyndesmotomeA hand-held, dental, surgical instrument designed for cutting desmodontal fibres and for detaching the alveolodental ligaments (the fibrous connective tissue surrounding the root of a tooth that separates it from and attaches it to the alveolar bone). It is typically made of high-grade stainless steel and has a long shaft with a handle at the proximal end and an angled scythe-like or knife-like blade at the distal end. 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
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
10889950126407Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126414Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126421Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
00348783007770Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007787Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007794Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007800Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007817Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007824Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007848Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00192896122444Gracey CuretteSONTEC INSTRUMENTS, INC.EMK2025-10-28
00192896119758Gracey CuretteSONTEC INSTRUMENTS, INC.EMK2024-09-05
00813677025135PDT, Inc.PDT, INC.EMK2024-08-12
B382SD9348330830Surgical DirectSurgical Direct, Inc.EMK2024-07-11
00813677024497PDT, Inc.PDT, INC.EMK2024-06-27