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Temporary Snap Abutment Engaging CC RP 3mm

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 38848

by Nobel Biocare AB

Identity

Trade Name
Temporary Snap Abutment Engaging CC RP 3mm EUDAMED
Nobel Biocare® FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name
Temporary prosthetic abutments EUDAMED
Temporary Snap Abutment Engaging CC RP 3mm FDA UDI
Model / Reference
38848 EUDAMEDFDA UDI
Description
Temporary Snap Abutment Engaging CC RP 3mm FDA UDI

Identifiers

Catalog Number
38848 FDA UDI
Primary DI / UDI-DI
07332747213157 EUDAMEDFDA UDI
Basic UDI-DI
733274700000017278 EUDAMED
FDA Product Code
NHA FDA UDI
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use 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

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Height — 3.000 Millimeter FDA UDI

Temporary Snap Abutment Engaging CC RP 3mm by Nobel Biocare AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Nobel Biocare AB
EUDAMED SRN
SE-MF-000000009

Sources (3)

  • EUDAMED f22ae05b-2071-4cf1-a074-cf9e0bcf1f9e 61 fields · synced Jun 18, 2026
  • FDA UDI 84f2e0b5-2fee-4cab-9a75-652bc179b358 37 fields · synced May 30, 2026
  • FDA 510(k) K161435 1 fields · synced May 18, 2026