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FDA UDI

Class II (US FDA UDI)

by Sweden & Martina Inc

Identity

Trade Name: PREMIUM ONE IMPLANT ZIRTI FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: PREMIUM ONE IMPLANT ZIRTI D.5.00 H.8.5 MM FDA UDI
Model / Reference: AS-ZT-500-085 FDA UDI
Description: PREMIUM ONE IMPLANT ZIRTI D.5.00 H.8.5 MM FDA UDI

Identifiers

Catalog Number: AS-ZT-500-085 FDA UDI
Primary DI / UDI-DI: D7701304773 FDA UDI
510(k) Number: K172560 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Screw endosteal dental implant, two-piece

The PREMIUM ONE IMPLANT ZIRTI is a high-quality, two-piece screw endosteal dental implant designed for surgical insertion into the alveolar and/or basal bone of the mandible or maxilla. Made from alloplastic materials such as titanium (Ti), stainless steel, or ceramic, this device provides support and retention for dental prosthesis, including bridges, single-tooth prostheses, and overdentures.

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Also classified as Screw endosteal dental implant, two-piece.

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ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
LW Vis Abutment — Ossvis Co., Ltd. · Class II
UF(II) Wide — DIO Corporation · Class II

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: Sweden & Martina Inc

Sources (1)

FDA UDI d4d47f87-94aa-42c8-9782-c4e799295d8d 36 fields · synced Jun 19, 2026

Premium One Implant Zirti

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)