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Outlink2 Implant Zirti

FDA UDI

Class II (US FDA UDI)

by Sweden & Martina Inc

Identity

Trade Name
OUTLINK2 IMPLANT ZIRTI FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
OUTLINK2 IMPLANT ZIRTI D.3.30 H.10 MM FDA UDI
Model / Reference
E2-ZT-330-100 FDA UDI
Description
OUTLINK2 IMPLANT ZIRTI D.3.30 H.10 MM FDA UDI

Identifiers

Catalog Number
E2-ZT-330-100 FDA UDI
Primary DI / UDI-DI
D77010645637 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

Outlink2 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 40edfb2e-17a4-42c3-a932-0a6d4828f08d 37 fields · synced May 30, 2026