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LOCATOR Fixed, compatible with Implant Direct

FDA UDI

Class I (US FDA UDI)

by Zest Anchors, LLC

Identity

Trade Name
LOCATOR Fixed, compatible with Implant Direct FDA UDI
Generic Name
Dental impression spacer FDA UDI
Device Name
LOCATOR White Block Out Spacer (20 pack) FDA UDI
Model / Reference
08514 FDA UDI
Description
LOCATOR White Block Out Spacer (20 pack) FDA UDI

Identifiers

Catalog Number
08514-ID-SB FDA UDI
Primary DI / UDI-DI
00840481134968 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental impression spacer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 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

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

Yes

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
High-level Disinfectant FDA UDI

Category: Dental impression spacer

LOCATOR Fixed, compatible with Implant Direct by Zest Anchors, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental impression spacer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zest Anchors, LLC

Sources (1)

  • FDA UDI 1619dc55-5b32-4aab-a294-36b0536d5c2f 35 fields · synced Jun 9, 2026