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Klockner

FDA UDI

Class II (US FDA UDI)

by Soadco, S.l.

Identity

Trade Name
KLOCKNER FDA UDI
Generic Name
Overdenture FDA UDI
Device Name
ESSENTIAL CONE K-LOCK ATTACHMENT [M-AT5-AP1] FDA UDI
Model / Reference
10 16 25 FDA UDI
Description
ESSENTIAL CONE K-LOCK ATTACHMENT [M-AT5-AP1] FDA UDI

Identifiers

Catalog Number
10 16 25 FDA UDI
Primary DI / UDI-DI
08435451634917 FDA UDI
510(k) Number
K230103 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Overdenture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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: Overdenture

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

Similar devices

Also classified as Overdenture.

Cleared under the same submission

K230103 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Soadco, S.l.

Sources (1)

  • FDA UDI 97351d05-821e-4df4-a180-07c75e74287d 36 fields · synced Jun 1, 2026