FDA.report

LOCATOR

Primary DI
00840481110146
Brand
LOCATOR
Company
Zest Anchors, LLC
Model
09001
Device description
Polishing Cap (Cut) 1/4
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

Related Records

Contact Domains

Product Codes

CodeName
EGGATTACHMENT, PRECISION, ALL

Product Code Classifications

CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840481110146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481110146008404811101468404811101460840481110146

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, single-useA collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 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