FDA.reportPublic FDA data

Instrument

Primary DI
00813110029539
Brand
Instrument
Company
BICON, LLC
Model
260-101-023
Catalog number
260-101-505
Device description
Thin Crestal Abutment Removal Tool
Published
2023-07-03
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
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813110029539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813110029539008131100295398131100295390813110029539

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
617-524-4443support@bicon.com

Regulatory Flags#

DUNS number
945015758
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
00813110029782Pliers260-801-070260-801-0702026-01-01
00813110029799Pliers260-801-075260-801-0752026-01-01
00813110029805Forceps Tips260-801-080260-801-0802026-01-01
00813110029812Forceps Tips260-801-085260-801-0852026-01-01
00813110028105Scan Body260-100-640260-100-6402020-03-24
00813110029744Scan Post260-100-810260-100-8102024-10-21
00813110029751Scan Post260-100-820260-100-8202024-10-21
00813110029768Scan Post260-100-830260-100-8302024-10-21
00813110027306Scan Post260-100-610260-100-6102016-05-06
00813110027313Scan Post260-100-620260-100-6202016-05-06
00813110027320Scan Post260-100-630260-100-6302016-05-06
00813110027276Universal Abutment260-365-790260-365-7902024-10-21
00813110027283Universal Abutment260-365-795260-365-7952024-10-21
00813110029775Temporary Abutment260-363-795260-363-7952024-10-21
00813110029669Temporary Abutment260-343-765260-343-7652024-08-05
00813110029676Temporary Abutment260-343-795260-343-7952024-08-05
00813110029683Universal Abutment260-340-710260-340-7102024-08-05
00813110029690Universal Abutment260-340-715260-340-7152024-08-05
00813110029706Universal Abutment260-340-720260-340-7202024-08-05
00813110029713Universal Abutment260-340-725260-340-7252024-08-05

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Primary DI, Brand, Company table
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10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
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08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
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