FDA.reportPublic FDA data

OSTEOTOME DRILL N.3

Primary DI
08435389801856
Brand
OSTEOTOME DRILL N.3
Company
BIOTECHNOLOGY INSTITUTE SL
Model
EC03
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435389801856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435389801856084353898018568435389801856

GMDN Terms#

Term, Definition table
TermDefinition
Titanium dental burA rotary cutting device, the working end of which is made from titanium (Ti), and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth and bone. It can also be used to cut metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
461665312
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435389828150SAMPLE PREPARATION KITKSAP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)CPUPC2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)CPUP2026-05-27
08435389830207STOP & GUIDE® BOXCCG2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMF35XS2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmTBA412026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1FCFA312026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1FCFA31C2026-05-27
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmTPMIEU12026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSFFXS2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0FCFA412026-05-27
08435389830825INTERNA 3.0 IMPLANT EXTENSION, 24 MMEAI3242026-03-31
08435389830832INTERNA 3.0 IMPLANT EXTENSION, 29 MMEAI3292026-03-31
08435389830849IMPLANT EXTENSION; INTERNA NARROW; 15MMINEAE152026-03-31
08435389830856INTERNA NARROW IMPLANT EXTENSION, 24 MMINEAE242026-03-31
08435389830863INTERNA NARROW IMPLANT EXTENSION, 29 MMINEAE292026-03-31
08435389830870INTERNA UNIVERSAL IMPLANT EXTENSOR, 15 MMINEAU152026-03-31
08435389830887INTERNA UNIVERSAL IMPLANT EXTENSOR , 24 MMINEAU242026-03-31
08435389830894INTERNA UNIVERSAL IMPLANT EXTENSOR, 29 MMINEAU292026-03-31
08435389828952EXTRACTOR FOR IMPLANTS 8EXIM82026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D661R100699C1AlpenCOLTENE/WHALEDENT INCEJL2026-06-05
D8120513291BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
D8120513301BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
00887919170488Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJL2026-05-27
08404535030006Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08404535030037Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMBIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
07630049901384C141 Allport bone cutterDiaswiss SAEJL2023-10-02
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC463140185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC48L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC48L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07