FDA.report

LOCATOR Overdenture Implant System

Primary DI
00840481131547
Brand
LOCATOR Overdenture Implant System
Company
Zest Anchors, LLC
Model
07516-05
Device description
LOCATOR Overdenture Implant, 4.9mmD x 14mmL, 4mm Cuff
Published
2022-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840481131547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481131547008404811315478404811315470840481131547

GMDN Terms

TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Device Sizes

TypeValueUnit
Length4Millimeter
Length14Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)649-0084quality@zestdent.com
+1 877-585-6290quality@zestdent.com

Regulatory Flags

DUNS number
078387192
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00840481136917LOCATOR R-Tx, Dentsply Sirona System 30013-0130013-01-DS-SB2026-02-18
00840481136924LOCATOR R-Tx, Dentsply Sirona System 30030-0130030-01-DS-SB2026-02-18
00840481136931LOCATOR Angled Abutment024692026-02-18
00840481136948LOCATOR Angled Abutment024702026-02-18
00840481136955LOCATOR Angled Abutment024712026-02-18
00840481136962LOCATOR Angled Abutment024722026-02-18
00840481136979LOCATOR Angled Abutment024732026-02-18
00840481136986LOCATOR Angled Abutment024742026-02-18

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