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On1 Healing Cap WP 1.5 mm

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 38699

by Nobel Biocare AB

Identity

Trade Name
On1 Healing Cap WP 1.5 mm EUDAMED
On1™ FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name
Healing abutments EUDAMED
On1 Healing Cap WP 1.5 mm FDA UDI
Model / Reference
38699 EUDAMEDFDA UDI
Description
On1 Healing Cap WP 1.5 mm FDA UDI

Identifiers

Catalog Number
38699 FDA UDI
Primary DI / UDI-DI
07332747191745 EUDAMEDFDA UDI
Basic UDI-DI
73327470000001236T EUDAMED
FDA Product Code
DZE 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
872.3640 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
Height — 1.500 Millimeter FDA UDI

On1 Healing Cap WP 1.5 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 c76bb0e7-676d-43b5-a72d-76ccc1c07509 61 fields · synced Jul 15, 2026
  • FDA UDI 8f75ea7d-c6d8-4bf0-b27a-0ca94dd9e77d 37 fields · synced May 30, 2026