FDA.reportPublic FDA data

LOCATOR R-Tx

Primary DI
00840481122149
Brand
LOCATOR R-Tx
Company
Zest Anchors, LLC
Model
30060-01-10
Device description
LOCATOR R-Tx, Scan Body, 10 Pack
Published
2022-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840481130731PrimaryGS10
00840481130748PrimaryGS10
00840481130755PrimaryGS10
00840481122149Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481130731008404811307318404811307310840481130731
00840481130748008404811307488404811307480840481130748
00840481130755008404811307558404811307550840481130755
00840481122149008404811221498404811221490840481122149

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression spacerA device comprised of thin layers of wax or other plastic materials intended to be applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. After producing the preliminary model, the device is discarded, thus providing an equidistant space between the oral structures and the impression tray that allows escape of excess impression material and entrapped air, and facilitates manipulation during final impression taking. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)649-0084quality@zestdent.com

Regulatory Flags#

DUNS number
078387192
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816594025448CONTACT MATRIX SYSTEM901022026-10-01
00816594025462CONTACT MATRIX SYSTEM910152026-10-01
00816594025714CONTACT MATRIX SYSTEM894392026-10-01
00816594025219NanoEZ90-001122022-12-23
00816594025226NanoEZ90-001132022-12-23
00816594025233NanoEZ90-001142022-12-23
00816594025240NanoEZ90-001152022-12-23
00816594025257NanoEZ90-001162022-12-23
00816594025264NanoEZ90-001182022-12-23
00816594025271NanoEZ90-001192022-12-23
00816594025288NanoEZ90-001202022-12-23
00816594025295NanoEZ90-001212022-12-23
00816594025301NanoEZ90-001222022-12-23
00816594025820NanoEZ90-001372022-12-23
00816594025837NanoEZ90-001382022-12-23
00816594025844NanoEZ90-001392022-12-23
00816594025851NanoEZ90-001402022-12-23
00816594025868NanoEZ90-001412022-12-23
00816594025875NanoEZ90-001422022-12-23
00816594025882NanoEZ90-001442022-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
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05397311032819Angled DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032826Straight DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
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05397311032895Driver BioHorizons 4.5HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032901Driver BioHorizons 5.7HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26