FDA.reportPublic FDA data

DD Implant Screw

Primary DI
EDDIDDNNAIS351
Brand
DD Implant Screw
Company
Dental Direkt GmbH
Model
NNA 35
Catalog number
DDNNAIS35
Device description
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw.The Dental Direkt Implant Screw is an accessory for the DD Solid Connect® products and can only be used in combination with them.The Dental Direkt Implant Screw is used to fix the abutment, ti-base or scanbody to the implant (two-part implant system).The Dental Direkt Implant Screw is available for different implant systems.
Published
2023-10-02
Public version status
Update
Distribution status
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
EDDIDDNNAIS351PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
EDDI963011DD cubeY® HL98H20 A1963012026-06-02
EDDI963051DD cubeY® HL98H25 A1963052026-06-02
EDDI963061DD cubeY® HL98H20 A2963062026-06-02
EDDI963071DD cubeY® HL98H25 A2963072026-06-02
EDDI963081DD cubeY® HL98H20 A3963082026-06-02
EDDI963091DD cubeY® HL98H25 A3963092026-06-02
EDDI963161DD cubeY® HL98H20 A3.5963162026-06-02
EDDI963171DD cubeY® HL98H25 A3.5963172026-06-02
EDDI963431DD cubeY® HL98H20 B1963432026-06-02
EDDI963441DD cubeY® HL98H20 B2963442026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809984989040S-PlantIDIS CO.,LTDNHA2026-10-07
07290114712675prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712682prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712699prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712705prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712712prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712729prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712736prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712743prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712750prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
08809984970895S-PlantIDIS CO.,LTDNHA2026-10-07
08809984981518S-PlantI Dis Co., Ltd.NHA2026-10-07
D7702764233TRANSGINGIVAL HEALING CAP H3MMSWEDEN & MARTINA SPANHA2026-10-07
D7702764243TRANSGINGIVAL HEALING CAP H5MMSWEDEN & MARTINA SPANHA2026-10-07
05712821014696Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014788Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014795Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014801Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014818Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014825Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014832Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014849Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06