Prestige Monophase 2 X 50 Ml

FDA UDI

Class II (US FDA UDI)

by Vannini Dental Industry Srl

Identity

Trade Name: PRESTIGE MONOPHASE 2 X 50 ML FDA UDI
Generic Name: Silicone dental impression material FDA UDI
Device Name: Vinylpolisiloxane for impressions FDA UDI
Model / Reference: 055210 FDA UDI
Description: Vinylpolisiloxane for impressions FDA UDI

Identifiers

Catalog Number: 055210 FDA UDI
Primary DI / UDI-DI: 08033712562223 FDA UDI
510(k) Number: K022653 FDA UDI
FDA Product Code: ELW FDA UDI
GMDN Term: Silicone dental impression material FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Total Volume — 100 Milliliter FDA UDI

Category: Silicone dental impression material

Prestige Monophase 2 X 50 Ml by Vannini Dental Industry Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Silicone dental impression material.

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BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
Polysil Multipurpose Regular Set — Scican GmbH · Class II
PERFECTO — CROWN DELTA CORP. · Class II
Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I

Cleared under the same submission

K022653 also covers:

PRESTIGE MONOPHASE 2X50 ML+12 YELLOW MIXING TIPS — VANNINI DENTAL INDUSTRY SRL

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: Vannini Dental Industry Srl

Sources (1)

FDA UDI be55fa40-a12c-40b0-949a-a7af5847b957 38 fields · synced May 30, 2026