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NobelSpeedy® Groovy RP 4.0x25mm

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 37613

by Nobel Biocare AB

Identity

Trade Name
NobelSpeedy® Groovy RP 4.0x25mm EUDAMED
NobelSpeedy® FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
Slightly tapered implants EUDAMED
NobelSpeedy® Groovy RP 4.0x25mm FDA UDI
Model / Reference
37613 EUDAMEDFDA UDI
Description
NobelSpeedy® Groovy RP 4.0x25mm FDA UDI

Identifiers

Catalog Number
37613 FDA UDI
Primary DI / UDI-DI
07332747161045 EUDAMEDFDA UDI
Basic UDI-DI
733274700000012773 EUDAMED
FDA Product Code
DZE FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3640 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
Outer Diameter — 4.000 Millimeter FDA UDI
Length — 25.000 Millimeter FDA UDI

NobelSpeedy® Groovy RP 4.0x25mm by Nobel Biocare AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

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 2e265834-4898-422c-a910-9493b88048bd 61 fields · synced Jun 19, 2026
  • FDA UDI dd3c0628-1c37-4341-96d4-66585f6900b2 37 fields · synced May 30, 2026
  • FDA 510(k) K160119 1 fields · synced May 18, 2026