FDA.reportPublic FDA data

BIOTANIUM

Primary DI
00810123450824
Brand
BIOTANIUM
Company
Basic Dental Implant Systems, Inc.
Model
OT101
Published
2026-04-20
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K013682000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013682000MODIFICATION TO BASIC DENTAL IMPLANT SYSTEMBasic Dental Implant Systems, Inc.2001-11-28DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123450824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123450824008101234508248101234508240810123450824

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
933988979
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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
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
00810123455294BIOTANIUMPI5122023-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04