Scan Healing Abutment

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref HAS5511RP

by ARUM DENTISTRY Co., Ltd.

Identity

Trade Name: Scan Healing Abutment EUDAMEDFDA UDI
Generic Name: Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name: Dental Healing Abutment EUDAMED
Model / Reference: HAS5511RP EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 08809917605795 EUDAMEDFDA UDI
Basic UDI-DI: 88000557HAAP EUDAMED
510(k) Number: K240091 FDA UDI
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: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dental implant suprastructure, temporary, preformed, single-use

Scan Healing Abutment by ARUM DENTISTRY Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: ARUM DENTISTRY Co., Ltd.

Sources (2)

FDA UDI 54eb9512-899a-4cbc-b9fa-e35f15c81bb0 33 fields · synced Oct 6, 2026
EUDAMED b40e7e9b-fbf9-4667-9584-a1f35f6d0778 61 fields · synced Oct 6, 2026

Scan Healing Abutment

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

Manufacturer

Sources (2)