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Locator

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 08044

by Zest Anchors, LLC

Identity

Trade Name
LOCATOR EUDAMEDFDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
LOCATOR ABUTMENT - STANDARD EUDAMED
LOCATOR Abutment for Klockner Essential Implant x 5.0mm FDA UDI
Model / Reference
08044 EUDAMEDFDA UDI
Description
LOCATOR Abutment for Klockner Essential Implant x 5.0mm FDA UDI

Identifiers

Primary DI / UDI-DI
00840481121609 EUDAMEDFDA UDI
Basic UDI-DI
08404811Z005ED EUDAMED
FDA Product Code
NHA FDA UDI
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Dental implant suprastructure, permanent, preformed 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

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

Yes

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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 5 Millimeter FDA UDI

Category: Dental implant suprastructure, permanent, preformed

Locator by Zest Anchors, LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure, permanent, preformed.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zest Anchors, LLC

Sources (2)

  • FDA UDI effd83b6-c738-4211-9bdd-938135e24a16 35 fields · synced Oct 7, 2026
  • EUDAMED fe9954a0-eb79-4e5c-9c63-402723197797 61 fields · synced Oct 7, 2026