FDA.reportPublic FDA data

Elos Accurate DigiLoc Housing

Primary DI
05712821016225
Brand
Elos Accurate DigiLoc Housing
Company
Elos Medtech Pinol A/S
Model
DLH-DH1-2
Catalog number
DLH-DH1-2
Device description
The Elos Accurate DigiLoc system for endosseous dental implants is designed for use with overdentures or partial dentures that are retained, either fully or partially, by endosseous implants in the mandible or maxilla. The Elos Accurate DigiLoc allows for the dentures to be removed and attached by the patient. The Elos Accurate DigiLoc is intended to be used by dental patients with edentulism.
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
05712821016225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821016225057128210162255712821016225

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

Regulatory Flags#

DUNS number
306155953
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05712821017307Elos Accurate DigiLoc AbutmentDLA-ZSV35-G2-1DLA-ZSV35-G2-12026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
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08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09