FDA.reportPublic FDA data

CORiTEC preMill

Primary DI
05712821011602
Brand
CORiTEC preMill
Company
Elos Medtech Pinol A/S
Model
CPMB-BCE34-1
Catalog number
CPMB-BCE34-1
Device description
The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Published
2024-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K231307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231307000Elos Accurate Customized AbutmentElos Medtech Pinol A/S2023-12-21NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712821011602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821011602057128210116025712821011602

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
Lot or batch
true
Manufacturing date on label
true
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

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Primary DI, Brand, Company table
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