Duns Number:306155953
Device Description: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental impla The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant andto support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented tothe base. The base and the superstructure form a patient-specific abutment that will support adefinitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate HybridBase Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengagingis intended for multi-unit restorations. Alternatively, a definitive multi-unit restorationmay be cemented directly to the Elos Accurate Hybrid Base.
Catalog Number
301457
Brand Name
Universal Base
Version/Model Number
301457
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201860
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
1d71f097-45d8-4494-8594-46037626a5b7
Public Version Date
August 25, 2021
Public Version Number
1
DI Record Publish Date
August 17, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |