FDA.reportPublic FDA data

LOCATOR

Primary DI
00840481130618
Brand
LOCATOR
Company
Zest Anchors, LLC
Model
07995
Device description
LOCATOR Guided Surgical Kit, Premium
Published
2023-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203701000Locator Overdenture Implant SystemIvory Super Holdco Inc. / Zest Anchors, LLC2021-04-15DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840481130618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481130618008404811306188404811306180840481130618

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various 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 reusable device.

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
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
00816594025448CONTACT MATRIX SYSTEM901022026-10-01
00816594025462CONTACT MATRIX SYSTEM910152026-10-01
00816594025714CONTACT MATRIX SYSTEM894392026-10-01
00816594025219NanoEZ90-001122022-12-23
00816594025226NanoEZ90-001132022-12-23
00816594025233NanoEZ90-001142022-12-23
00816594025240NanoEZ90-001152022-12-23
00816594025257NanoEZ90-001162022-12-23
00816594025264NanoEZ90-001182022-12-23
00816594025271NanoEZ90-001192022-12-23
00816594025288NanoEZ90-001202022-12-23
00816594025295NanoEZ90-001212022-12-23
00816594025301NanoEZ90-001222022-12-23
00816594025820NanoEZ90-001372022-12-23
00816594025837NanoEZ90-001382022-12-23
00816594025844NanoEZ90-001392022-12-23
00816594025851NanoEZ90-001402022-12-23
00816594025868NanoEZ90-001412022-12-23
00816594025875NanoEZ90-001422022-12-23
00816594025882NanoEZ90-001442022-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114711548prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-13
07290114711630prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-13
07290114712491prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-13
07290114710039Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710046prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710114prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710138prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710145prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710312Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710732Indirect Transfer 13mm open trayCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114712675prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712682prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712699prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712705prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712712prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712729prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712736prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712743prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712750prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
08809984970420S-PlantIDIS CO.,LTDDZE2026-10-07
07290114712149prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712767prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712774prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712781prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712798prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712804prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712811prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712828prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712835prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712842prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06