FDA.reportPublic FDA data

LOCATOR, compatible with Nobel Biocare

Primary DI
00840481138478
Brand
LOCATOR, compatible with Nobel Biocare
Company
Zest Anchors, LLC
Model
08540-10
Catalog number
08540-10-NB-SB
Device description
LOCATOR® EXTENDED RANGE MALE PROCESSING PACKAGE 10 PACK
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
00840481138478PrimaryGS10
10840481138475Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481138478008404811384788404811384780840481138478
1084048113847510840481138475

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
+1(877)649-0084quality@zestdent.com

Regulatory Flags#

DUNS number
078387192
Device count
10
DM exempt
false
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

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
00840481138423LOCATOR, compatible with Nobel BiocareZest Anchors, LLCEGG2026-09-29
00840481138454LOCATOR, compatible with Nobel BiocareZest Anchors, LLCEGG2026-09-29
08800076418523T-L Cap SetTruabutment Korea Co.,LtdEGG2026-09-04
08059224151519OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224151526OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224160993OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161006OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161013OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161037OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161044OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161051OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197746OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197753OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197760OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197777OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197784OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197791OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224218571PLUSRHEIN 83 SRLEGG2026-08-27
08059224218588PLUSRHEIN 83 SRLEGG2026-08-27
08059224218595PLUSRHEIN 83 SRLEGG2026-08-27
08059224218601PLUSRHEIN 83 SRLEGG2026-08-27
08059224218618PLUSRHEIN 83 SRLEGG2026-08-27
08059224218625PLUSRHEIN 83 SRLEGG2026-08-27
08059224218632PLUSRHEIN 83 SRLEGG2026-08-27
08059224218649PLUSRHEIN 83 SRLEGG2026-08-27
08059224218656PLUSRHEIN 83 SRLEGG2026-08-27
08059224218663PLUSRHEIN 83 SRLEGG2026-08-27
08059224218670PLUSRHEIN 83 SRLEGG2026-08-27
08059224218687PLUSRHEIN 83 SRLEGG2026-08-27
08059224218694PLUSRHEIN 83 SRLEGG2026-08-27