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Rep. Straight Abutment, H1 Mm

FDA UDI

Class II (US FDA UDI)

by Sweden & Martina Inc

Identity

Trade Name
REP. STRAIGHT ABUTMENT, H1 MM FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
REP. STRAIGHT ABUTMENT, H1 MM GLOBAL D. 3.80 MM FDA UDI
Model / Reference
U-ABU-380-1 FDA UDI
Description
REP. STRAIGHT ABUTMENT, H1 MM GLOBAL D. 3.80 MM FDA UDI

Identifiers

Catalog Number
U-ABU-380-1 FDA UDI
Primary DI / UDI-DI
D77010190935 FDA UDI
510(k) Number
K142242 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Rep. Straight Abutment, H1 Mm 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 4bc8f5c2-badd-4297-a059-c3e87ca71144 37 fields · synced Jun 8, 2026