FDA.reportPublic FDA data

BIOTANIUM

Primary DI
00810123455386
Brand
BIOTANIUM
Company
Basic Dental Implant Systems, Inc.
Model
PI521
Device description
4.8mmDrill – 21mm Length
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
00810123455386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123455386008101234553868101234553860810123455386

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard 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

Regulatory Flags#

DUNS number
933988979
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810123453146BIOTANIUMO3511PW2026-04-21
00810123453153BIOTANIUMO3513PW2026-04-21
00810123453160BIOTANIUMO3515PW2026-04-21
00810123453177BIOTANIUMO4011PW 2026-04-21
00810123450787BIOTANIUMOT1052026-04-20
00810123450794BIOTANIUMOT1042026-04-20
00810123450800BIOTANIUMOT1402026-04-20
00810123450817BIOTANIUMOT1392026-04-20
00810123450824BIOTANIUMOT1012026-04-20
00810123454709BIOTANIUMPI5002023-09-28
00810123455416BIOTANIUMPI5242023-09-28
00810123454716BIOTANIUMPI5012023-09-28
00810123454723BIOTANIUMPI5022023-09-28
00810123454730BIOTANIUMPI5032023-09-28
00810123454747BIOTANIUMPI5042023-09-28
00810123454754BIOTANIUMPI5052023-09-28
00810123454761BIOTANIUMPI5062023-09-28
00810123455263BIOTANIUMPI5092023-09-28
00810123455270BIOTANIUMPI5102023-09-28
00810123455287BIOTANIUMPI5112023-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535036985Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-01
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
00810194409448AiraAIRA, LLCEJL2026-08-25
00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
00810226100572AiraAIRA, LLCEJL2026-08-25
00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25