FDA.report

LOCATOR

Primary DI
00840481135989
Brand
LOCATOR
Company
Zest Anchors, LLC
Model
07576
Device description
Premium Surgical Kit for LOCATOR Implant
Published
2026-05-22
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

Related Records

Contact Domains

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840481135989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481135989008404811359898404811359890840481135989

GMDN Terms

TermDefinition
Dental implant kitA collection of prefabricated dental devices and components, which includes a dental implant, intended to be used during dental surgery and laboratory procedures to create and implant the foundation of a reconstructed tooth. In addition to the dental implant, it includes a dental abutment(s) (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), and additional components to facilitate restoration (e.g., abutment analog, abutment impression cap). This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 800-262-2310quality@zestdent.com

Regulatory Flags

DUNS number
078387192
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
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
00840481136030LOCATOR, compatible with Implant Direct08530-2008530-20-ID-SB2026-02-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840481135996LOCATORZest Anchors, LLCDZE2026-05-22
00840481136009LOCATORZest Anchors, LLCDZE2026-05-22
08806395269907ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269914ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269921ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269938ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269945ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269952ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269969ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269976ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269983ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269990ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270002ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100118DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20