FDA.reportPublic FDA data

NA

Primary DI
07630031721921
Brand
NA
Company
Institut Straumann AG
Model
surgically Invasive Instruments
Catalog number
046.510
Device description
Osteotome angled, for bone condensation, Ø 2.2mm, stainless steel
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07630031721921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031721921076300317219217630031721921

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.2Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031773258NAsurgically Invasive Instruments034.364S2026-03-14
07630031750853Straumann Cares Bone Level Screw Retained Bars / BridgesBridges (implant borne)010.12482026-03-04
07630031750860Straumann Cares Bone Level Screw Retained Bars / BridgesBridges (implant borne)010.12492026-03-04
07630031772718NAsurgically Invasive Instruments044.782S2026-03-04
07630031772725NAsurgically Invasive Instruments044.783S2026-03-04
07630031772732NAsurgically Invasive Instruments044.784S2026-03-04
07630031772749NAsurgically Invasive Instruments044.785S2026-03-04
07630031772756NAsurgically Invasive Instruments044.786S2026-03-04
07630031772763NAsurgically Invasive Instruments044.787S2026-03-04
07630031772770NAsurgically Invasive Instruments044.788S2026-03-04
07630031772787NAsurgically Invasive Instruments044.789S2026-03-04
07630031772794NAsurgically Invasive Instruments044.790S2026-03-04
07630031772800NAsurgically Invasive Instruments044.791S2026-03-04
07630031772817NAsurgically Invasive Instruments044.792S2026-03-04
07630031772824NAsurgically Invasive Instruments044.793S2026-03-04
07630031772831NAsurgically Invasive Instruments044.794S2026-03-04
07630031772848NAsurgically Invasive Instruments044.795S2026-03-04
07630031772855NAsurgically Invasive Instruments044.796S2026-03-04
07630031772862NAsurgically Invasive Instruments044.797S2026-03-04
07630031772879NAsurgically Invasive Instruments066.1101S2026-03-04

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