Wide Platform Implant Ca D:5.0 L:11.5

FDA UDI

Class II (US FDA UDI)

by Biotechnology Institute Sl

Identity

Trade Name: WIDE PLATFORM IMPLANT CA D:5.0 L:11.5 FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Model / Reference: IRPACA5011 FDA UDI

Identifiers

Primary DI / UDI-DI: 08435389814887 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: Length — 11.5 Millimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Wide Platform Implant Ca D:5.0 L:11.5 by Biotechnology Institute Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
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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: Biotechnology Institute Sl

Sources (1)

FDA UDI 0b1a6d96-d4d9-4dd6-a45c-26b0b32d9258 34 fields · synced May 31, 2026