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Healing Abutment

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref HAA4010MRef HA5508GRRef HA4008GMRef HAA5510RRef HA7510GRRef HA4003GMRef HA4005GRRef HA7506GRRef HA4003GRRef HA7503RRef HA4004GRRef HA5504RRef HA6505GRRef HA4510GMRef NBHA506Ref HA4010GRRef HA4503GRRef NBHA607Ref HAA5507RRef HA4502GRRef HA6509RRef HA4502GMRef NBHA453Ref HA7508RRef HAA4503MRef HA5509GRRef HA4009RRef HA4002RRef HA4507RRef HA4504GMRef HA4508RRef HA4004MRef HA4005RRef HA6507RRef HA7502GRRef HA7504GRRef NBHA452Ref HAA7508RRef HA4009GRRef HA6504RRef HA4509GRRef HA4509GMRef HAA4008RRef HA4009GMRef HAA4005MRef HA5504GRRef NBHA603Ref HA4010MRef NBHA708Ref HAA6503RRef HA4007GMRef NBHA602Ref NBHA403Ref NBHA706Ref HA4509MRef NBHA454Ref HA5503RRef HAA4010RRef HA4507GMRef HAA4007MRef HAA5505RRef HA4006GMRef HAA6509RRef HA4006RRef HAA4508MRef HA7509RRef HAA6510RRef HA4507MRef HAA4504RRef HA4504GRRef NBHA606Ref HA4507GRRef HAA4509RRef HA6505RRef HAA6508RRef NBHA505Ref HAA5506RRef HAA4504MRef NBHA703Ref HAA5502RRef NBHA609Ref NBHA457Ref HA4506MRef HA6504GRRef HAA4508RRef NBHA408Ref HAA5508RRef HA4506GMRef HA4004GMRef HA4510GRRef HA4510RRef HA4508MRef HA6506RRef NBHA507Ref HA7502RRef HAA7504RRef NBHA702Ref HAA4007RRef HA4007MRef HA4504MRef HA5506GRRef HA4003MRef HA5507RRef HAA4510RRef HAA4502RRef HA6508GRRef NBHA508Ref HA6507GRRef HAA4502MRef NBHA406Ref HA6502GRRef HA4505GRRef NBHA458Ref HA4505MRef HAA5509RRef HA5508RRef HAA6507RRef HAA7502RRef HAA4003MRef NBHA503Ref NBHA455Ref HAA4004MRef HA7510RRef HA5505GRRef NBHA502

by ARUM DENTISTRY Co., Ltd.

Identity

Trade Name
Healing Abutment EUDAMEDFDA UDI
ARUM NB Healing Abutment FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Dental Healing Abutment EUDAMED
Model / Reference
HA4510R EUDAMEDFDA UDI
HA4009R EUDAMEDFDA UDI
HA4505GR EUDAMEDFDA UDI
HA4004GR EUDAMEDFDA UDI
HA5505GR EUDAMEDFDA UDI
HA4507GM EUDAMEDFDA UDI
HA6509R EUDAMEDFDA UDI
HA4008GM EUDAMEDFDA UDI
HA6502GR EUDAMEDFDA UDI
HA4010GR EUDAMEDFDA UDI
HA4004M EUDAMEDFDA UDI
HA4504M EUDAMEDFDA UDI
HA7502GR EUDAMEDFDA UDI
HA6507R EUDAMEDFDA UDI
HA4509M EUDAMEDFDA UDI
HA5509GR EUDAMEDFDA UDI
HA4504GM EUDAMEDFDA UDI
HA4006GM EUDAMEDFDA UDI
HA4010M EUDAMEDFDA UDI
HA7502R EUDAMEDFDA UDI
HA4007M EUDAMEDFDA UDI
HA5503R EUDAMEDFDA UDI
HA5508R EUDAMEDFDA UDI
HA7508R EUDAMEDFDA UDI
HA6505R EUDAMEDFDA UDI
HA4510GR EUDAMEDFDA UDI
HA4003GR EUDAMEDFDA UDI
HA4006R EUDAMEDFDA UDI
HA4508R EUDAMEDFDA UDI
HA4506M EUDAMEDFDA UDI
HA4005R EUDAMEDFDA UDI
HA4503GR EUDAMEDFDA UDI
HA4507R EUDAMEDFDA UDI
HA4507GR EUDAMEDFDA UDI
HA6507GR EUDAMEDFDA UDI
HA5508GR EUDAMEDFDA UDI
HA6504R EUDAMEDFDA UDI
HA4504GR EUDAMEDFDA UDI
HA4009GR EUDAMEDFDA UDI
HA5507R EUDAMEDFDA UDI
HA4003GM EUDAMEDFDA UDI
HA5506GR EUDAMEDFDA UDI
HA4509GM EUDAMEDFDA UDI
HA4004GM EUDAMEDFDA UDI
HA4505M EUDAMEDFDA UDI
HA7506GR EUDAMEDFDA UDI
HA6505GR EUDAMEDFDA UDI
HA4005GR EUDAMEDFDA UDI
HA4508M EUDAMEDFDA UDI
HA4502GM EUDAMEDFDA UDI
HA4507M EUDAMEDFDA UDI
HA7510GR EUDAMEDFDA UDI
HA6508GR EUDAMEDFDA UDI
HA4009GM EUDAMEDFDA UDI
HA4007GM EUDAMEDFDA UDI
HA6506R EUDAMEDFDA UDI
HA4502GR EUDAMEDFDA UDI
HA6504GR EUDAMEDFDA UDI
HA7503R EUDAMEDFDA UDI
HA7509R EUDAMEDFDA UDI
HA4509GR EUDAMEDFDA UDI
HA4506GM EUDAMEDFDA UDI
HA5504GR EUDAMEDFDA UDI
HA7510R EUDAMEDFDA UDI
HA4002R EUDAMEDFDA UDI
HA4003M EUDAMEDFDA UDI
HA5504R EUDAMEDFDA UDI
HA4510GM EUDAMEDFDA UDI
HA7504GR EUDAMEDFDA UDI
HAA4010M EUDAMED
HAA5510R EUDAMED
NBHA506 EUDAMED
NBHA607 EUDAMED
HAA5507R EUDAMED
NBHA453 EUDAMED
HAA4503M EUDAMED
NBHA452 EUDAMED
HAA7508R EUDAMED
HAA4008R EUDAMED
HAA4005M EUDAMED
NBHA603 EUDAMED
NBHA708 EUDAMED
HAA6503R EUDAMED
NBHA602 EUDAMED
NBHA403 EUDAMED
NBHA706 EUDAMED
NBHA454 EUDAMED
HAA4010R EUDAMED
HAA4007M EUDAMED
HAA5505R EUDAMED
HAA6509R EUDAMED
HAA4508M EUDAMED
HAA6510R EUDAMED
HAA4504R EUDAMED
NBHA606 EUDAMED
HAA4509R EUDAMED
HAA6508R EUDAMED
NBHA505 EUDAMED
HAA5506R EUDAMED
HAA4504M EUDAMED
NBHA703 EUDAMED
HAA5502R EUDAMED
NBHA609 EUDAMED
NBHA457 EUDAMED
HAA4508R EUDAMED
NBHA408 EUDAMED
HAA5508R EUDAMED
NBHA507 EUDAMED
HAA7504R EUDAMED
NBHA702 EUDAMED
HAA4007R EUDAMED
HAA4510R EUDAMED
HAA4502R EUDAMED
NBHA508 EUDAMED
HAA4502M EUDAMED
NBHA406 EUDAMED
NBHA458 EUDAMED
HAA5509R EUDAMED
HAA6507R EUDAMED
HAA7502R EUDAMED
HAA4003M EUDAMED
NBHA503 EUDAMED
NBHA455 EUDAMED
HAA4004M EUDAMED
NBHA502 EUDAMED
HA5503GR FDA UDI

Identifiers

Primary DI / UDI-DI
08809917603623 EUDAMEDFDA UDI
08809917603524 EUDAMEDFDA UDI
08809917604200 EUDAMEDFDA UDI
08809917604101 EUDAMEDFDA UDI
08809917604293 EUDAMEDFDA UDI
08809917604040 EUDAMEDFDA UDI
08809917603791 EUDAMEDFDA UDI
08809917603968 EUDAMEDFDA UDI
08809917604354 EUDAMEDFDA UDI
08809917604163 EUDAMEDFDA UDI
08809917603296 EUDAMEDFDA UDI
08809917603388 EUDAMEDFDA UDI
08809917604446 EUDAMEDFDA UDI
08809917603777 EUDAMEDFDA UDI
08809917603432 EUDAMEDFDA UDI
08809917604330 EUDAMEDFDA UDI
08809917604019 EUDAMEDFDA UDI
08809917603944 EUDAMEDFDA UDI
08809917603357 EUDAMEDFDA UDI
08809917603814 EUDAMEDFDA UDI
08809917603326 EUDAMEDFDA UDI
08809917603647 EUDAMEDFDA UDI
08809917603692 EUDAMEDFDA UDI
08809917603876 EUDAMEDFDA UDI
08809917603753 EUDAMEDFDA UDI
08809917604255 EUDAMEDFDA UDI
08809917604095 EUDAMEDFDA UDI
08809917603494 EUDAMEDFDA UDI
08809917603609 EUDAMEDFDA UDI
08809917603401 EUDAMEDFDA UDI
08809917603487 EUDAMEDFDA UDI
08809917604187 EUDAMEDFDA UDI
08809917603593 EUDAMEDFDA UDI
08809917604224 EUDAMEDFDA UDI
08809917604408 EUDAMEDFDA UDI
08809917604323 EUDAMEDFDA UDI
08809917603746 EUDAMEDFDA UDI
08809917604194 EUDAMEDFDA UDI
08809917604156 EUDAMEDFDA UDI
08809917603685 EUDAMEDFDA UDI
08809917603913 EUDAMEDFDA UDI
08809917604309 EUDAMEDFDA UDI
08809917604064 EUDAMEDFDA UDI
08809917603920 EUDAMEDFDA UDI
08809917603395 EUDAMEDFDA UDI
08809917604484 EUDAMEDFDA UDI
08809917604385 EUDAMEDFDA UDI
08809917604118 EUDAMEDFDA UDI
08809917603425 EUDAMEDFDA UDI
08809917603999 EUDAMEDFDA UDI
08809917603418 EUDAMEDFDA UDI
08809917604521 EUDAMEDFDA UDI
08809917604415 EUDAMEDFDA UDI
08809917603975 EUDAMEDFDA UDI
08809917603951 EUDAMEDFDA UDI
08809917603760 EUDAMEDFDA UDI
08809917604170 EUDAMEDFDA UDI
08809917604378 EUDAMEDFDA UDI
08809917603821 EUDAMEDFDA UDI
08809917603883 EUDAMEDFDA UDI
08809917604248 EUDAMEDFDA UDI
08809917604033 EUDAMEDFDA UDI
08809917604286 EUDAMEDFDA UDI
08809917603890 EUDAMEDFDA UDI
08809917603456 EUDAMEDFDA UDI
08809917603289 EUDAMEDFDA UDI
08809917603654 EUDAMEDFDA UDI
08809917604071 EUDAMEDFDA UDI
08809917604460 EUDAMEDFDA UDI
08809917602558 EUDAMED
08809917602916 EUDAMED
08809917604736 EUDAMED
08809917604828 EUDAMED
08809917602886 EUDAMED
08809917604620 EUDAMED
08809917602572 EUDAMED
08809917604613 EUDAMED
08809917603074 EUDAMED
08809917602718 EUDAMED
08809917602503 EUDAMED
08809917604781 EUDAMED
08809917604910 EUDAMED
08809917602930 EUDAMED
08809917604774 EUDAMED
08809917604545 EUDAMED
08809917604897 EUDAMED
08809917604637 EUDAMED
08809917602732 EUDAMED
08809917602527 EUDAMED
08809917602862 EUDAMED
08809917602992 EUDAMED
08809917602626 EUDAMED
08809917603005 EUDAMED
08809917602763 EUDAMED
08809917604811 EUDAMED
08809917602817 EUDAMED
08809917602985 EUDAMED
08809917604729 EUDAMED
08809917602879 EUDAMED
08809917602589 EUDAMED
08809917604866 EUDAMED
08809917602831 EUDAMED
08809917604842 EUDAMED
08809917604668 EUDAMED
08809917602800 EUDAMED
08809917604590 EUDAMED
08809917602893 EUDAMED
08809917604743 EUDAMED
08809917603036 EUDAMED
08809917604859 EUDAMED
08809917602701 EUDAMED
08809917602824 EUDAMED
08809917602749 EUDAMED
08809917604750 EUDAMED
08809917602565 EUDAMED
08809917604576 EUDAMED
08809917604675 EUDAMED
08809917602909 EUDAMED
08809917602978 EUDAMED
08809917603012 EUDAMED
08809917602480 EUDAMED
08809917604705 EUDAMED
08809917604644 EUDAMED
08809917602497 EUDAMED
08809917604699 EUDAMED
08800055743684 FDA UDI
Basic UDI-DI
88000557HAAP EUDAMED
510(k) Number
K240091 FDA UDI
K222131 FDA UDI
K213506 FDA UDI
FDA Product Code
NHA FDA UDI
DZE FDA UDI
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
872.3640 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIFDA 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 UDIFDA 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 UDIFDA UDI

Manufacturing Date

Yes

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

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

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

Similar devices

Also classified as Dental implant suprastructure, temporary, preformed, single-use.

Cleared under the same submission

K240091 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ARUM DENTISTRY Co., Ltd.

Sources (195)

  • FDA UDI 7ea7657e-58d2-4ba7-b4b3-1c5a0f55871c 33 fields · synced Oct 1, 2026
  • FDA UDI ba707ce7-cf61-46ab-90ab-21e4ebaaec62 33 fields · synced May 22, 2026
  • FDA UDI 1586689c-4a03-4345-a2ec-d38fc2b8c837 33 fields · synced May 24, 2026
  • FDA UDI eaf24f66-e17a-436c-a083-9ae4f633f1d7 33 fields · synced May 24, 2026
  • FDA UDI be60a75a-a023-4939-95a9-7f150cc449f8 33 fields · synced May 24, 2026
  • FDA UDI 5352b31d-c499-4c4f-9355-8344c7011db6 33 fields · synced May 24, 2026
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  • FDA UDI aa4c04b6-db07-46b8-83e2-d6938272232c 33 fields · synced May 25, 2026
  • FDA UDI 4a22d5d1-88c1-4072-ba1d-4c1b462bb2e6 33 fields · synced May 25, 2026
  • FDA UDI 16bed70f-00e8-4d59-b4f5-ea9b652caf44 33 fields · synced May 27, 2026
  • FDA UDI 3a6b4f46-6b8f-4bf4-b525-9b01055aadca 33 fields · synced May 29, 2026
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  • FDA UDI 4473030e-4273-46b9-8216-781217755267 33 fields · synced May 30, 2026
  • FDA UDI 950efec5-ea36-4da1-a349-afba8edd3a4b 33 fields · synced May 30, 2026
  • FDA UDI 66a87d7c-1e86-4333-87a3-fd7c18ed14be 33 fields · synced May 30, 2026
  • FDA UDI 0fb8287e-1784-4d2c-9d4b-2fbbd41d5d59 33 fields · synced May 30, 2026
  • FDA UDI dca2be74-d18a-4f13-ada3-7daa42dc1c89 33 fields · synced May 30, 2026
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  • FDA UDI f1b8197f-ede5-4ccb-912a-3180fc9cd232 33 fields · synced May 30, 2026
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  • FDA UDI 146300fe-1c63-4204-b3b3-0a7fd372af39 33 fields · synced May 30, 2026
  • FDA UDI 45d894e4-84c0-421c-8440-6f07865ae591 33 fields · synced May 30, 2026
  • FDA UDI 9a109521-0ced-4f78-918d-b985f2a42898 33 fields · synced May 30, 2026
  • EUDAMED 19d12a7a-5127-4be1-a6b0-d7c3f4460a59 61 fields · synced Jun 20, 2026
  • EUDAMED 2f900639-640c-4807-abe2-1c5d2c4afcc4 61 fields · synced Jun 20, 2026
  • EUDAMED e0473555-c3e4-4339-b879-3f38aad701a8 61 fields · synced Jun 20, 2026
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