FDA.report

LOCATOR, compatible with AstraTech Implant System

Primary DI
00840481126840
Brand
LOCATOR, compatible with AstraTech Implant System
Company
Zest Anchors, LLC
Model
08913
Catalog number
08913-AT-SB
Device description
LOCATOR Abutment Driver for Torque Wrench (Latch Type) 23mm
Published
2022-07-01
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
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840481126840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481126840008404811268408404811268400840481126840

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Device Sizes

TypeValueUnit
Length23Millimeter

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
true
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

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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
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00840481136931LOCATOR Angled Abutment024692026-02-18
00840481136948LOCATOR Angled Abutment024702026-02-18
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00840481136962LOCATOR Angled Abutment024722026-02-18
00840481136979LOCATOR Angled Abutment024732026-02-18
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