FDA.reportPublic FDA data

Milling Blank

Primary DI
00813110029348
Brand
Milling Blank
Company
BICON, LLC
Model
260-651-790
Catalog number
260-651-790
Device description
10mm UA5 Milling Blank - 3.0mm Tall Post
Published
2022-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853788000DB PRECISION IMPLANT SYSTEMDriskell Bioengineering1985-10-31DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813110029348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813110029348008131100293488131100293480813110029348

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Contacts#

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

Regulatory Flags#

DUNS number
945015758
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10813110026665SynthoGraft260-400-125260-400-1252016-03-07
10813110026672SynthoGraft260-400-150260-400-1502016-03-07
10813110026689SynthoGraft260-400-151260-400-1512016-03-07
10813110026696SynthoGraft260-400-152260-400-1522016-03-07
10813110026702SynthoGraft260-400-500260-400-5002016-03-07
10813110026719SynthoGraft260-400-501260-400-5012016-03-07
10813110026726SynthoGraft260-400-502260-400-5022016-03-07
10813110026733SynthoGraft260-400-525260-400-5252016-03-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970154S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970161S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970178S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970185S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970192S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970208S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970222S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970239S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970246S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970253S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970260S-PlantIDIS CO.,LTDDZE2026-10-20
07290114710756prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710787prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710800prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710831prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710848prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711654prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711661prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712026prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712170prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712651prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14