FDA.reportPublic FDA data

Guided Tray

Primary DI
00813110024817
Brand
Guided Tray
Company
BICON, LLC
Model
260-104-935
Catalog number
260-104-935
Device description
3.5mm Guided Surgical Tray
Published
2016-06-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813110024817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813110024817008131100248178131100248170813110024817

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. 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
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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ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
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