Tl 04.1mm Rn, S, Slactive Tizr 6, 8, 10, 12, 14, 16mm Dental Implants

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name: TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Tapered Effect Implant, D 4.8mm WN, SLActive® 14mm, Roxolid®, Loxim™ FDA UDI
Model / Reference: SLActive Roxolid TL FDA UDI
Description: Tapered Effect Implant, D 4.8mm WN, SLActive® 14mm, Roxolid®, Loxim™ FDA UDI

Identifiers

Catalog Number: 033.624S FDA UDI
Primary DI / UDI-DI: 07630031716316 FDA UDI
510(k) Number: K122855 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

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 4.8 Millimeter FDA UDI
Length — 14 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Tl 04.1mm Rn, S, Slactive Tizr 6, 8, 10, 12, 14, 16mm Dental Implants by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K122855 also covers:

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 76041e25-95e5-4593-ab5a-e3145e4a70ac 38 fields · synced Jun 8, 2026