Straumann® BLC and TLC Implants

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name: Straumann® BLC and TLC Implants FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: TLC SP Implant, Ø 3.75mm RT, SLActive® 10mm, Roxolid® FDA UDI
Model / Reference: SLActive Roxolid TL FDA UDI
Description: TLC SP Implant, Ø 3.75mm RT, SLActive® 10mm, Roxolid® FDA UDI

Identifiers

Catalog Number: 035.7310S FDA UDI
Primary DI / UDI-DI: 07630031765246 FDA UDI
510(k) Number: K230108 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.75 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Straumann® BLC and TLC Implants by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K230108 also covers:

Straumann® BLC and TLC Implants — Institut Straumann SA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Institut Straumann SA

Sources (1)

FDA UDI a93f94fa-d5db-4b8e-ae60-9b93b511686b 38 fields · synced Jun 6, 2026