15 Shouldered Abutment - Wide Emergence

FDA UDI

Class II (US FDA UDI)

by Surgikor, LLC

Identity

Trade Name: 15 Shouldered Abutment - Wide Emergence FDA UDI
Generic Name: Basket endosteal dental implant, two-piece FDA UDI
Device Name: "4.3mm x L7.5mm, w/ 3mm Shoulder Height, 15Deg. Angle,Wide Emergence, Conical Connection, Wide Platform" FDA UDI
Model / Reference: SW153WC FDA UDI
Description: "4.3mm x L7.5mm, w/ 3mm Shoulder Height, 15Deg. Angle,Wide Emergence, Conical Connection, Wide Platform" FDA UDI

Identifiers

Primary DI / UDI-DI: D824SW153WC0 FDA UDI
FDA Product Code: DZE FDA UDI
NHA FDA UDI
GMDN Term: Basket endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
872.3630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Basket endosteal dental implant, two-piece

15 Shouldered Abutment - Wide Emergence by Surgikor, LLC — 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: Surgikor, LLC

Sources (1)

FDA UDI 45965399-2d3c-46a5-b9f8-18409b9cca79 33 fields · synced May 31, 2026