Versalis S

FDA UDI

Class II (US FDA UDI)

by S.I.N. - Sistema DE Implante Nacional S.A.

Identity

Trade Name: VERSALIS S FDA UDI
Generic Name: Screw endosteal dental implant, one-piece FDA UDI
Device Name: IMP. VERSALIS S MT16° Ø3.8X15MM FDA UDI
Model / Reference: IVMT 3815 FDA UDI
Description: IMP. VERSALIS S MT16° Ø3.8X15MM FDA UDI

Identifiers

Primary DI / UDI-DI: 07899995240330 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, one-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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Screw endosteal dental implant, one-piece

Versalis S by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: S.I.N. - Sistema DE Implante Nacional S.A.

Sources (1)

FDA UDI db1e2000-f3a9-4195-81ea-b65184037058 33 fields · synced Jun 7, 2026