FDA.reportPublic FDA data

SCHWERT

Primary DI
E89617001270
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
1700-127
Catalog number
1700-127
Device description
Osteotome concave, conical,bayonett 2,7 Graduation 7 / 10 / 13 / 15 / 18 / 20
Published
2023-02-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E89617001270PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E89628870SCHWERT288728872025-12-16
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
E896294760SCHWERT29476294762025-06-10
E896294980SCHWERT29498294982025-06-10
E8964320SCHWERT4324322025-06-10
E896169520SCHWERT1695-21695-22025-05-19
E8965000260SCHWERT5000-265000-262025-04-08
E8965000270SCHWERT5000-275000-272025-04-08
E8965000280SCHWERT5000-285000-282025-04-08
E8965000540SCHWERT5000-545000-542025-04-08
E8961033610SCHWERT1033-611033-612025-04-07
E8961137170SCHWERT1137-171137-172025-04-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251436931086KOHLERKohler Medizintechnik GmbHEMM2026-03-12
00841013120572Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
00841013120589Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
00841013120596Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
D9282001491H0OSTEOTOME, 7", 4mm SLIGHT CURVE MARKINGS 12-9-6-3mm, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001492H0OSTEOTOME, 7", 4mm, STRONG CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001493H0OSTEOTOME, 7", 4mm, OFFSET, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D928200149H0OSTEOTOME, 7", 4mm STRAIGHT, MARKINGS 12-9-6-3mm, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001501H0OSTEOTOME, 7", 6mm, SLIGHT CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001502H0OSTEOTOME, 7", 6mm, STRONG CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001503H0OSTEOTOME, 7", 6mm, OFFSET, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D928200150H0OSTEOTOME, 7", 6mm, STRAIGHT, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
00841336106260Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMM2025-11-11
00190776401306MillenniumAvalign Technologies, Inc.EMM2025-06-10
D92820029090BURTON PTERYGOID OSTEOTOME 9MMW.H. Holden, Inc.EMM2025-05-21
00190776394646MillenniumAvalign Technologies, Inc.EMM2025-05-07
G586NS38796080NOVOSURGICALNOVO SURGICAL, INC.EMM2025-05-02
00194613108656MSI Precision Specialty InstrumentsMed Saver, Inc.EMM2025-03-21
D928105382010BONE CHISEL 2.5MM, 6" S/EW.H. Holden, Inc.EMM2025-03-19
D928105382020BONE CHISEL 4MM, 6" S/EW.H. Holden, Inc.EMM2025-03-19
EZPF2474485HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
EZPF4774831HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
EZPF4774841HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
D9281675060MINI-LEXER, OSTEOTOME 6mm, STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281675080MINI-LEXER, OSTEOTOME 8mm, STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281675100MINI-LEXER, OSTEOTOME 10mm STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281676060MINI-LEXER, GOUGE 6mmW.H. Holden, Inc.EMM2024-12-18
D9281676080MINI-LEXER, GOUGE 8mmW.H. Holden, Inc.EMM2024-12-18
D9281676100MINI-LEXER, GOUGE 10mmW.H. Holden, Inc.EMM2024-12-18
D9281790900IDR KIT ACCORDING TO DR. ROSAW.H. Holden, Inc.EMM2024-12-18