FDA.reportPublic FDA data

LOCATOR

Primary DI
00840481100949
Brand
LOCATOR
Company
Zest Anchors, LLC
Model
08013
Device description
LOCATOR Bar Threaded Sleeve, 2-56
Published
2022-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00840481100949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481100949008404811009498404811009490840481100949

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
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
00840481100901LOCATOR091042022-07-08
00840481100918LOCATOR091052022-07-08
00840481100970LOCATOR080162022-07-08
00840481126574LOCATOR, compatible with AstraTech Implant System0839308393-AT-SB2022-07-01
00840481127113LOCATOR, compatible with Ankylos System0839308393-FD2022-07-01
00840481127458LOCATOR, compatible with Anthogyr System0839308393-AN-SB2022-07-01
00840481127588LOCATOR®083932022-03-11
00840481100178LOCATOR®08528-102022-03-26
00893202000899LOCATOR®08394-202022-03-11
00840481135088LOCATOR Fixed, compatible with Implant Direct0959909599-ID-M2023-12-22
00840481132681LOCATOR Fixed095992023-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H0005KX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
H0005TX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
ESTOI0107K5000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-14
ESTOV0003X2600StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-08
ESTOI6501K3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-05-22
ESTOI6501K4500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-05-22
00840481134104LOCATOR, compatible with Implant DirectZest Anchors, LLCEGG2023-11-10
18056039211336NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211503NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211510NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211527NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
07640166516125Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093121Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093145Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093268Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
ESTOH0004K20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K30StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004X20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004Z10StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOU0001Z315K0StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001X2500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001Z3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
00810053771891PrimeLocIPBEGG2022-12-15
07630031758743NAInstitut Straumann AGEGG2022-12-02
07630031758750NAInstitut Straumann AGEGG2022-12-02
07630031758767NAInstitut Straumann AGEGG2022-12-02
07630031758774NAInstitut Straumann AGEGG2022-12-02
07630031758781NAInstitut Straumann AGEGG2022-12-02
07630031758798NAInstitut Straumann AGEGG2022-12-02