FDA.reportPublic FDA data

Straumann® BLC and TLC Implants

Primary DI
07630031780225
Brand
Straumann® BLC and TLC Implants
Company
Institut Straumann AG
Model
SLA Roxolid BL
Catalog number
035.8310S
Device description
BLC Implant, Ø 4.0mm RB, SLA 10mm, Roxolid
Published
2025-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
K230108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230108000Straumann® BLC and TLC ImplantsInstitut Straumann AG2023-09-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031780225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031780225076300317802257630031780225

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter
Outer Diameter4Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031782298Straumann Modular CassetteStorage Systems / Cassettes041.8192026-05-07
07630031770936Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53442026-04-08
07630031770943Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53452026-04-08
07630031770950Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53462026-04-08
07630031770967Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53552026-04-08
07630031770974Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53562026-04-08
07630031770981Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53572026-04-08
07630031770998Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53582026-04-08
07630031771001Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53592026-04-08
07630031771018Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53602026-04-08
07630031771025Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53612026-04-08
07630031771032Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53622026-04-08
07630031771049Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53632026-04-08
07630031771056Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53642026-04-08
07630031771063Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53652026-04-08
07630031771070Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53662026-04-08
07630031771087Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53672026-04-08
07630031771094Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53682026-04-08
07630031771100Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53692026-04-08
07630031771117Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53702026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28