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Global Implant Zirti

FDA UDI

Class II (US FDA UDI)

by Sweden & Martina Inc

Identity

Trade Name
GLOBAL IMPLANT ZIRTI FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
GLOBAL IMPLANT ZIRTI D.3.80 H.8.5 MM FDA UDI
Model / Reference
U-ZT-380-085 FDA UDI
Description
GLOBAL IMPLANT ZIRTI D.3.80 H.8.5 MM FDA UDI

Identifiers

Catalog Number
U-ZT-380-085 FDA UDI
Primary DI / UDI-DI
D7700891693 FDA UDI
510(k) Number
K142242 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Global Implant Zirti by Sweden & Martina Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K142242 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sweden & Martina Inc

Sources (1)

  • FDA UDI b56487d5-c2a9-4b5d-9ce1-6693fd9defe5 37 fields · synced Jun 8, 2026