FDA.reportPublic FDA data

Elos Accurate® Analog for Printed Models

Primary DI
15712821001433
Brand
Elos Accurate® Analog for Printed Models
Company
Elos Medtech Pinol A/S
Model
PMA-ATO30-50
Catalog number
N/a
Device description
The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).
Published
2020-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15712821001433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1571282100143315712821001433

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306155953
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712821016225Elos Accurate DigiLoc HousingDLH-DH1-2DLH-DH1-22026-06-26
05712821016232Elos Accurate DigiLoc Retention RingDLR-W-6DLR-W-62026-06-26
05712821017123Elos Accurate DigiLoc AbutmentDLA-ATE36-G2-1DLA-ATE36-G2-12026-06-26
05712821017130Elos Accurate DigiLoc AbutmentDLA-ATE36-G3-1DLA-ATE36-G3-12026-06-26
05712821017147Elos Accurate DigiLoc AbutmentDLA-ATE36-G4-1DLA-ATE36-G4-12026-06-26
05712821017154Elos Accurate DigiLoc AbutmentDLA-ATE42-G2-1DLA-ATE42-G2-12026-06-26
05712821017161Elos Accurate DigiLoc AbutmentDLA-ATE42-G3-1DLA-ATE42-G3-12026-06-26
05712821017178Elos Accurate DigiLoc AbutmentDLA-ATE42-G4-1DLA-ATE42-G4-12026-06-26
05712821017185Elos Accurate DigiLoc AbutmentDLA-SBX45-G2-1DLA-SBX45-G2-12026-06-26
05712821017192Elos Accurate DigiLoc AbutmentDLA-SBX45-G3-1DLA-SBX45-G3-12026-06-26
05712821017208Elos Accurate DigiLoc AbutmentDLA-SBX45-G4-1DLA-SBX45-G4-12026-06-26
05712821017215Elos Accurate DigiLoc AbutmentDLA-NBA35-G2-1DLA-NBA35-G2-12026-06-26
05712821017222Elos Accurate DigiLoc AbutmentDLA-NBA35-G3-1DLA-NBA35-G3-12026-06-26
05712821017239Elos Accurate DigiLoc AbutmentDLA-NBA35-G4-1DLA-NBA35-G4-12026-06-26
05712821017246Elos Accurate DigiLoc AbutmentDLA-NBA43-G2-1DLA-NBA43-G2-12026-06-26
05712821017253Elos Accurate DigiLoc AbutmentDLA-NBA43-G3-1DLA-NBA43-G3-12026-06-26
05712821017260Elos Accurate DigiLoc AbutmentDLA-NBA43-G4-1DLA-NBA43-G4-12026-06-26
05712821017277Elos Accurate DigiLoc AbutmentDLA-NGM45-G2-1DLA-NGM45-G2-12026-06-26
05712821017284Elos Accurate DigiLoc AbutmentDLA-NGM45-G3-1DLA-NGM45-G3-12026-06-26
05712821017291Elos Accurate DigiLoc AbutmentDLA-NGM45-G4-1DLA-NGM45-G4-12026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14