FDA.reportPublic FDA data

DD Prefab Starter Kit

Primary DI
EDDICAM110151
Brand
DD Prefab Starter Kit
Company
Dental Direkt GmbH
Model
SilaMill N4
Catalog number
CAM 1101.5
Device description
The DD Prefab Starter Kit SilaMill N4 contains one SilaMill N4 holder, one bar, four black M4 screws, three silver M4 screws, one screwdriver SW 3mm, three calibration bodies and three prefabs.
Published
2024-02-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

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
K191111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191111000DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH2023-01-11NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDDICAM110151PrimaryHIBCC0
EDDICAM110159Unit of UseHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+495225863190info@dentaldirekt.de

Regulatory Flags#

DUNS number
313214171
Device count
3
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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