FDA.reportPublic FDA data

DD Prefab Starter Kit

Primary DI
EDDICAM110441
Brand
DD Prefab Starter Kit
Company
Dental Direkt GmbH
Model
SilaMill R5
Catalog number
CAM 1104.4
Device description
The DD Prefab Starter Kit SilaMill R5 contains one SilaMill R5 ring holder, two bars, four black M4 screws, six silver M4 screws, one screwdriver SW 3mm, one screwdriver SW 2.5mm, five calibration bodies and six 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
EDDICAM110441PrimaryHIBCC0
EDDICAM110449Unit 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
6
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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EDDI963071DD cubeY® HL98H25 A2963072026-06-02
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EDDI963451DD cubeY® HL98H20 C1963452026-06-02
EDDI963821DD cubeY® HL98H20 C2963822026-06-02
EDDI963831DD cubeY® HL98H20 D2963832026-06-02
EDDI963841DD cubeY® HL98H20 0M2963842026-06-02
EDDI963851DD cubeY® HL98H25 B1963852026-06-02
EDDI963861DD cubeY® HL98H25 B2963862026-06-02
EDDI963941DD cubeY® HL98H25 C1963942026-06-02
EDDI963951DD cubeY® HL98H25 C2963952026-06-02
EDDI963961DD cubeY® HL98H25 D2963962026-06-02
EDDI963971DD cubeY® HL98H25 0M2963972026-06-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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