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Zygoma 17° Abutment Multi-unit RP 3 mm

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 29315

by Nobel Biocare AB

Identity

Trade Name
Zygoma 17° Abutment Multi-unit RP 3 mm EUDAMED
NobelPro Line™ FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Multi-unit prosthetic abutments EUDAMED
Zygoma 17° Abutment Multi-unit RP 3 mm FDA UDI
Model / Reference
29315 EUDAMEDFDA UDI
Description
Zygoma 17° Abutment Multi-unit RP 3 mm FDA UDI

Identifiers

Catalog Number
29315 FDA UDI
Primary DI / UDI-DI
07332747189049 EUDAMEDFDA UDI
Basic UDI-DI
73327470000001687H EUDAMED
FDA Product Code
NHA FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Height — 3.000 Millimeter FDA UDI
Angle — 17.000 degree FDA UDI

Zygoma 17° Abutment Multi-unit RP 3 mm by Nobel Biocare AB — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nobel Biocare AB
EUDAMED SRN
SE-MF-000000009

Sources (2)

  • EUDAMED b8557fd8-87d4-4cf2-9c62-7a4d60cb60b8 61 fields · synced Jul 8, 2026
  • FDA UDI 14f7bcf5-0376-480f-a08e-17ecf85ea71c 37 fields · synced May 30, 2026