FDA.report

LOCATOR, Dentsply Sirona System

Primary DI
00840481131899
Brand
LOCATOR, Dentsply Sirona System
Company
Zest Anchors, LLC
Model
30018-01
Catalog number
30018-01-DS
Device description
LOCATOR R-Tx Processing Spacer (4 pack)
Published
2022-07-06
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
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840481131899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481131899008404811318998404811318990840481131899

GMDN Terms

TermDefinition
Dental impression spacerA device comprised of thin layers of wax or other plastic materials intended to be applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. After producing the preliminary model, the device is discarded, thus providing an equidistant space between the oral structures and the impression tray that allows escape of excess impression material and entrapped air, and facilitates manipulation during final impression taking. This is a single-use device.

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
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

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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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