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Klockner

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 10 05 06Model Basic UDI

by Soadco, S.l.

Identity

Trade Name
EC TITANIUM HEALING ABUTMENT [3.5MM] EUDAMED
KLOCKNER FDA UDI
Generic Name
Intramucosal dental implant FDA UDI
Device Name
EC TITANIUM HEALING ABUTMENT [3.5MM] FDA UDI
Model / Reference
10 05 06 EUDAMEDFDA UDI
Basic UDI EUDAMED
Description
EC TITANIUM HEALING ABUTMENT [3.5MM] FDA UDI

Identifiers

Catalog Number
10 05 06 FDA UDI
Primary DI / UDI-DI
08435451644244 EUDAMEDFDA UDI
Basic UDI-DI
84354516TF29QY EUDAMED
510(k) Number
K080224 FDA UDI
FDA Product Code
NHA FDA UDI
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Intramucosal dental implant FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Market of Registration
Spain 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

No

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

Category: Intramucosal dental implant

Klockner by Soadco, S.l. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Intramucosal dental implant.

Cleared under the same submission

K080224 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Soadco, S.l.

Sources (2)

  • FDA UDI 20b33f2b-172e-4565-b22a-b8f7e25eeff9 36 fields · synced Jun 18, 2026
  • EUDAMED 702bdf43-0395-40d1-9bbb-418965c1e82d 61 fields · synced Jun 18, 2026