FDA.reportPublic FDA data

PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Primary DI
07630031704665
Brand
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Company
Institut Straumann AG
Model
Bridges (implant borne)
Catalog number
010.7085
Device description
Advanced Hybrid, 6 Implants, Ti
Published
2019-08-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHOBAR, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHOBar, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031704665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031704665076300317046657630031704665

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
07630031778086NAsurgically Invasive Instruments066.50632026-06-03
07630031778093NAsurgically Invasive Instruments066.50642026-06-03
07630031778109NAsurgically Invasive Instruments066.50652026-06-03
07630031778116NAsurgically Invasive Instruments066.50662026-06-03
07630031778123NAsurgically Invasive Instruments066.50672026-06-03
07630031778130NAsurgically Invasive Instruments066.50682026-06-03
07630031778147NAsurgically Invasive Instruments066.50692026-06-03
07630031778154NAsurgically Invasive Instruments066.50702026-06-03
07630031778161NAsurgically Invasive Instruments066.50712026-06-03
07630031778192NAsurgically Invasive Instruments066.50742026-06-03
07630031778208NAsurgically Invasive Instruments066.50752026-06-03
07630031778215NAsurgically Invasive Instruments066.50762026-06-03
07630031778222NAsurgically Invasive Instruments066.50772026-06-03
07630031778239NAsurgically Invasive Instruments066.50782026-06-03
07630031778260NAsurgically Invasive Instruments066.50812026-06-03
07630031778277NAsurgically Invasive Instruments066.50822026-06-03
07630031778284NAsurgically Invasive Instruments066.50832026-06-03
07630031778291NAsurgically Invasive Instruments066.50842026-06-03
07630031778307NAsurgically Invasive Instruments066.50852026-06-03
07630031778338NAsurgically Invasive Instruments066.50882026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776352066MillenniumAvalign Technologies, Inc.EHO2023-06-23
EZPF41905000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
EZPF41905010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
EZPF4190702S0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
07630031724502NAInstitut Straumann AGEHO2022-11-10
07630031724519NAInstitut Straumann AGEHO2022-11-10
00842092112847HaderPreat CorporationEHO2022-10-24
00842092113103PreatPreat CorporationEHO2022-10-24
00842092129784PreatPreat CorporationEHO2022-10-24
00842092130834PreatPreat CorporationEHO2022-10-24
00842092131923PreatPreat CorporationEHO2022-10-24
00842092133224PreatPreat CorporationEHO2022-10-24
00842092133231PreatPreat CorporationEHO2022-10-24
00842092133330PreatPreat CorporationEHO2022-10-24
00842092133408PreatPreat CorporationEHO2022-10-24
00842092133576PreatPreat CorporationEHO2022-10-24
00842092134450PreatPreat CorporationEHO2022-10-24
00842092134467PreatPreat CorporationEHO2022-10-24
00842092134610PreatPreat CorporationEHO2022-10-24
00842092136522PreatPreat CorporationEHO2022-10-24
00842092139745PreatPreat CorporationEHO2022-10-24
00842092139769PreatPreat CorporationEHO2022-10-24
00842092139783PreatPreat CorporationEHO2022-10-24
00842092139806PreatPreat CorporationEHO2022-10-24
00842092139837PreatPreat CorporationEHO2022-10-24
00842092139851PreatPreat CorporationEHO2022-10-24
00842092139875PreatPreat CorporationEHO2022-10-24
00842092139882PreatPreat CorporationEHO2022-10-24
00842092139905PreatPreat CorporationEHO2022-10-24
00842092139929PreatPreat CorporationEHO2022-10-24