FDA.reportPublic FDA data

Elos Accurate DigiLoc Abutment

Primary DI
05712821017161
Brand
Elos Accurate DigiLoc Abutment
Company
Elos Medtech Pinol A/S
Model
DLA-ATE42-G3-1
Catalog number
DLA-ATE42-G3-1
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253774000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253774000Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S2026-05-20NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712821017161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821017161057128210171615712821017161

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
false
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
05712821014696Elos Accurate Hybrid Base G EngagingHBE-ATE30-G1.0HBE-ATE30-G1.02026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingHBE-ATE30-G2.0HBE-ATE30-G2.02026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingHBE-ATE30-G3.0HBE-ATE30-G3.02026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingHBE-ATE30-G4.0HBE-ATE30-G4.02026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingHBE-ATE36-G1.0HBE-ATE36-G1.02026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingHBE-ATE36-G2.0HBE-ATE36-G2.02026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingHBE-ATE36-G3.0HBE-ATE36-G3.02026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingHBE-ATE36-G4.0HBE-ATE36-G4.02026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingHBE-ATE42-G1.0HBE-ATE42-G1.02026-10-06
05712821014788Elos Accurate Hybrid Base G EngagingHBE-ATE42-G2.0HBE-ATE42-G2.02026-10-06
05712821014795Elos Accurate Hybrid Base G EngagingHBE-ATE42-G3.0HBE-ATE42-G3.02026-10-06
05712821014801Elos Accurate Hybrid Base G EngagingHBE-ATE42-G4.0HBE-ATE42-G4.02026-10-06
05712821014818Elos Accurate Hybrid Base G EngagingHBE-ATE48-G1.0HBE-ATE48-G1.02026-10-06
05712821014825Elos Accurate Hybrid Base G EngagingHBE-ATE48-G2.0HBE-ATE48-G2.02026-10-06
05712821014832Elos Accurate Hybrid Base G EngagingHBE-ATE48-G3.0HBE-ATE48-G3.02026-10-06
05712821014849Elos Accurate Hybrid Base G EngagingHBE-ATE48-G4.0HBE-ATE48-G4.02026-10-06
05712821014856Elos Accurate Hybrid Base G EngagingHBE-ATE54-G1.0HBE-ATE54-G1.02026-10-06
05712821014863Elos Accurate Hybrid Base G EngagingHBE-ATE54-G2.0HBE-ATE54-G2.02026-10-06
05712821014870Elos Accurate Hybrid Base G EngagingHBE-ATE54-G3.0HBE-ATE54-G3.02026-10-06
05712821014887Elos Accurate Hybrid Base G EngagingHBE-ATE54-G4.0HBE-ATE54-G4.02026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494138plant Implant System8dent Inc.NHA2026-10-15
088000968498028plant Implant System8dent Inc.NHA2026-10-15
088000968501748plant Implant System8dent Inc.NHA2026-10-15
088000968515228plant Implant System8dent Inc.NHA2026-10-15
088000968515398plant Implant System8dent Inc.NHA2026-10-15
088000968515538plant Implant System8dent Inc.NHA2026-10-15
088000968516078plant Implant System8dent Inc.NHA2026-10-15
088000968516148plant Implant System8dent Inc.NHA2026-10-15
088000968516218plant Implant System8dent Inc.NHA2026-10-15
088000968516388plant Implant System8dent Inc.NHA2026-10-15
088000968588358plant Implant System8dent Inc.NHA2026-10-15
088000968600678plant Implant System8dent Inc.NHA2026-10-15
088000968603028plant Implant System8dent Inc.NHA2026-10-15
088000968609068plant Implant System8dent Inc.NHA2026-10-15
088000968616758plant Implant System8dent Inc.NHA2026-10-15
088000968620618plant Implant System8dent Inc.NHA2026-10-15
088000968621848plant Implant System8dent Inc.NHA2026-10-15
088000968623378plant Implant System8dent Inc.NHA2026-10-15
088000968688728plant Implant System8dent Inc.NHA2026-10-15
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