Klockner

FDA UDI

Class II (US FDA UDI)

by Soadco, S.l.

Identity

Trade Name: KLOCKNER FDA UDI
Generic Name: Dental implant suprastructure kit FDA UDI
Device Name: EC G TEMPORARY OCTACONE® ABUTMENT [U-AT0.4-AP9] FDA UDI
Model / Reference: 10 10 19 G FDA UDI
Description: EC G TEMPORARY OCTACONE® ABUTMENT [U-AT0.4-AP9] FDA UDI

Identifiers

Catalog Number: 10 10 19 G FDA UDI
Primary DI / UDI-DI: 08435451601896 FDA UDI
510(k) Number: K122988 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure kit 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure kit

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

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Also classified as Dental implant suprastructure kit.

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Paltop — Paltop Advanced Dental Solutions, Ltd. · Class II
Prosthetic Accessories — A.B. DENTAL DEVICES LTD · Class II
CERALOG® PL Abutment straight Ø 3.8 mm, GH 1.0 mm — CeramTec Schweiz GmbH · Class II
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Blue Sky Bio, LLC. — BLUE SKY BIO LLC · Class II

Cleared under the same submission

K122988 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Soadco, S.l.

Sources (1)

FDA UDI f023da98-6491-4923-abd2-d88b1cc763fc 36 fields · synced May 30, 2026