FDA.reportPublic FDA data

LOCATOR

Primary DI
00840481100963
Brand
LOCATOR
Company
Zest Anchors, LLC
Model
08014
Device description
LOCATOR Bar Threaded Sleeve, M2 X .40 6H
Published
2022-07-08
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGGATTACHMENT, PRECISION, ALL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840481100963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481100963008404811009638404811009630840481100963

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

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
1
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
00840481135408LOCATOR075652026-05-22
00840481135972LOCATOR075752026-05-22
00840481135989LOCATOR075762026-05-22
00840481135996LOCATOR079962026-05-22
00840481136009LOCATOR079972026-05-22
00840481138065LOCATOR R-TXC26-001-0022026-05-22
00840481138218LOCATOR Fixed096192026-05-22
00840481138225LOCATOR Fixed096202026-05-22
00840481138232LOCATOR Fixed096212026-05-22
00840481135286MICROPRIME90-002492026-03-10
00840481135293MICROPRIME90-002502026-03-10
00840481135309MICROPRIME90-002512026-03-10
10840481136013BULK EZ947912026-03-10
00840481132421LOCATOR R-Tx, Dentsply Sirona System 30715-0230715-02-DS-SB2026-02-18
00840481132438LOCATOR R-Tx, Dentsply Sirona System 30715-0330715-03-DS-SB2026-02-18
00840481132445LOCATOR R-Tx, Dentsply Sirona System 30715-0430715-04-DS-SB2026-02-18
00840481132452LOCATOR R-Tx, Dentsply Sirona System 30715-0530715-05-DS-SB2026-02-18
00840481132469LOCATOR R-Tx, Dentsply Sirona System 30715-0630715-06-DS-SB2026-02-18
00840481135903LOCATOR Angled Abutment020992026-02-18
00840481136023LOCATOR, compatible with Implant Direct08515-2008515-20-ID-SB2026-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481136023LOCATOR, compatible with Implant DirectZest Anchors, LLCEGG2026-02-18
00840481136917LOCATOR R-Tx, Dentsply Sirona System Zest Anchors, LLCEGG2026-02-18
00840481136924LOCATOR R-Tx, Dentsply Sirona System Zest Anchors, LLCEGG2026-02-18
07640239932562Dalbo®-ClassicCendres+Métaux SAEGG2026-02-16
07640239932579Dalbo®-ClassicCendres+Métaux SAEGG2026-02-16
08059224127798OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224129044PLUSRHEIN 83 SRLEGG2026-02-10
08059224129099PLUSRHEIN 83 SRLEGG2026-02-10
08059224129143PLUSRHEIN 83 SRLEGG2026-02-10
08059224133041OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224133058OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224134260OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224167503PLUSRHEIN 83 SRLEGG2026-02-10
08059224167510PLUSRHEIN 83 SRLEGG2026-02-10
08059224167534PLUSRHEIN 83 SRLEGG2026-02-10
08059224167541PLUSRHEIN 83 SRLEGG2026-02-10
08059224167558PLUSRHEIN 83 SRLEGG2026-02-10
08059224167565PLUSRHEIN 83 SRLEGG2026-02-10
08059224167572PLUSRHEIN 83 SRLEGG2026-02-10
08059224167589PLUSRHEIN 83 SRLEGG2026-02-10
08059224167596PLUSRHEIN 83 SRLEGG2026-02-10
08059224167602PLUSRHEIN 83 SRLEGG2026-02-10
08059224167619PLUSRHEIN 83 SRLEGG2026-02-10
08059224167626PLUSRHEIN 83 SRLEGG2026-02-10
08059224167633PLUSRHEIN 83 SRLEGG2026-02-10
08059224167640OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224185040OT CAPRHEIN 83 SRLEGG2026-02-10
08059224209234OT CAPRHEIN 83 SRLEGG2026-02-10
08059224209241OT CAPRHEIN 83 SRLEGG2026-02-10
08059224209272OT CAPRHEIN 83 SRLEGG2026-02-10