(238 days)
The AB Dental Devices implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
17 Integral implant, 15 Conical implant, P15 Temporary abutment, P12-T,L Temporary flat connection abutment, and P16 Straight adaptor are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
AB Dental implants are designed to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing functions.
The provided document K112440 is a 510(k) premarket notification for AB Dental Devices Implants and Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than strictly proving safety and effectiveness through clinical trials with pre-defined acceptance criteria.
Therefore, the document does not contain explicit "acceptance criteria" in the sense of performance metrics with specific thresholds that were met by a study. Instead, the "acceptance" by the FDA is based on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis of the provided information in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, there are no explicit acceptance criteria and corresponding reported device performance metrics in the format typically seen with clinical efficacy studies. The "performance" is demonstrated through comparison to predicates and non-clinical tests.
The document highlights the following non-clinical tests performed on the AB Dental implants:
| Acceptance Criterion (Implied by Predicate Comparison and Standards) | Reported Device Performance (AB Dental) | Predicate Device Performance (where available) |
|---|---|---|
| Mechanical Strength (Fatigue Testing - ISO 14801) | Successfully passed. | Not explicitly stated; implied by predicate equivalence. |
| Surface Characteristics (SEM surface analysis and topography) | Produced a clean, textured surface. | Not explicitly stated; implied by predicate equivalence. |
| Pullout Strength Test (for 17 Integral Implants) | 162.9 N | 135.8 N (M.I.S Implant Technologies UNO) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests. The document mentions "a selected number of its dental implants" for fatigue testing.
- Data Provenance: The testing was conducted by AB Dental Devices Ltd., an Israeli company. The data is thus of Israeli origin. The studies are non-clinical (laboratory/bench testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This concept is not applicable as this is a 510(k) submission for substantial equivalence based on non-clinical testing, not a study requiring expert-established ground truth for a diagnostic device. The "ground truth" here is compliance with established engineering standards and comparison to predicate devices, which is assessed by the FDA reviewers.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the sense of a clinical or observational study requiring adjudication of findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) submission for dental implants and accessories, not a diagnostic imaging device. An MRMC study is not relevant to this type of device and submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This device is a physical dental implant and accessories, not a software algorithm or AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Existing International Standards: Compliance with ISO 14801 for dynamic fatigue testing.
- Comparison to Predicate Devices: Demonstrating that the new devices have similar technological characteristics, indications for use, and performance to already legally marketed devices.
- Non-Clinical Test Results: The measured pullout strength, surface characteristics, and fatigue performance are the "truth" for the device's physical properties.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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AB DENTAL SUMMARY
APR 1 8 2012
Company
AB Dental Devices Ltd.
3 Habosem St, Ashdod
lsrael
Telephone: (+972) 8-853-1388
Fax: (+972) 8-8522262
FDA Establishment Registration # 3005663340
Contact
Dr. Charles Hurwitz Regulatory Consultant MedicSense Ltd POB 367 Ramat Hasharon 47103 lsrael Phone: +972 3 9233666 Fax: +972 3 9231274 Email: charles@medicsense.com
Classification Name
Per 21 CFR 872.3640
- Endosseous Dental Implants and Accessories Product Code . DZE
- Abutment, Implant, Dental Endosseous. Product Code NHA .
Device Description
AB Dental implants are designed to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing functions.
2
{1}------------------------------------------------
The purpose of this submission is to add new implants, abutments and other items and to receive approval for a new surface treatment to previously-approved implants.
Indications for Use
The AB Dental Devices implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
17 Integral implant, 15 Conical implant, P15 Temporary abutment, P12-T,L Temporary flat connection abutment, and P16 Straight adaptor are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
{2}------------------------------------------------
Identification of the Legally Marketed Predicate Devices Used to Claim Substantial Equivalence
| AB Dental Product | Predicate and K number | Predicate and K number |
|---|---|---|
| 12 Screw Type | AB Dental 12, screw type,K051719 | M.I.S Implant Technologies, Bio-Com, K040807 |
| I5 Conical | AB Dental, I5 Conical, K051719 | M.I.S Implant Technologies,Lance, K040807 |
| I7 Integral | AB Dental, I7 One-piece,K051719 | M.I.S Implant Technologies, Unoone piece screw type, K080162 |
| I10 Trapeze | Nobel Biocare, Nobel Active,K102436 | ADIN, Touareg WP5mmD,K081751 |
| P1-Non Hexed Abutment | AB Dental, P1-Non HexedAbutment, K051719 | Biohorizon, Titanium TemporaryAbutments - Non-hexed,K103691 |
| P3 Abutment Anti-rotation | AB Dental, P3 Abutment Anti-rotation, K051719 | Biohorizon, Internal Laser-LokAbutment, K103691 |
| P3N-Narrow Anti-rotationAbutment | AB Dental, P3 Narrow AbutmentAnti-rotation, K051719 | MIS, MN-MAC10, Narrowplatform cementing post, NP,K040807 |
| P3W - Wide anti-rotationabutment | MIS, MD-WMAC1 Widecementing post, SP, K040807 | AlfaBio tec, TLAW, K063364 |
| P3W - Wide anti-rotationabutment | MIS, MD-WMAC1 Widecementing post, SP, K040807 | AlfaBio tec, TLAW, K063364 |
| P9HG-3.75,11 Gold ComposedHex Abutment | AlfaBio tec, TLABG, K063364 | MIS, MG-GPC10 Direct goldplastic cylinder with hex. Internalhex, K063364 |
| P12-3.75 - Flat ConnectionAbutment | Adin, FC-6013,6018, K081751 | |
| P12-3.75-T - Temporary FlatConnection Abutment | Adin, FC-6013,6018, K081751 | |
| P15-3x - Temporary Abutmentfor Immediate Loading | Alpha-Bio Tec, Straight TitaniumAbutments ETLA, K063364 | |
| PO-P6H for Aesthetic Abutmentwith Hex | Alpha Bio, HCT, K042654 | |
| PO-Titanium Healing Cap | Alpha Bio, HS, K042654 | Adin, WP-0046,0047,0048,0049,0050,K081751 |
| P16-Straight adaptor | MIS, Pilier Multi Unit, K040807 |
The following predicate devices are cited:
. ﻓ
ﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
{3}------------------------------------------------
| Current | Predicate | Predicate | |
|---|---|---|---|
| IMPLANTS | AB Dental | AB Dental | M.I.S Implant Technologies |
| ProductName | I2 Screw Type | I2 Screw Type | Bio-Com |
| K Number | K051719 | K051719 | K040807 |
| PlacementMethod | Dual-stepsurgery. Laterexposurerequired. | Dual-step surgery.Later exposurerequired. | Dual-step surgery. Laterexposure required. |
| Indicationfor Use | For use in densebone | For use in densebone | For use in dense bone |
| Length(s) | 8,10,11.5,13,16,18,20 | 8,10,11.5,13,16,18,20 | 8,10,11.5,13,16 |
| Availablediameters(mm) | 3.25,3.75,4.2,4.5,5,6 | 3.25,3.75,4.2,4.5,5,6 | 3.3,3.75,4.2,4.7 |
| IntegratedAbutment | No | No | No |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium alloy Ti-6Al-4V-ELI.Grade-5. | Titanium alloy. Grade-4. |
| ExternalSurface | Sandblasted andacid etchedsurface . (HA) | Sandblasted andacid etchedsurface (SLA). | Sandblasted and acid etchedsurface (SLA). |
| SelfTapping | Yes | Yes | Yes |
| AB Dental | AB Dental | M.I.S Implant Technologies | |
| ProductName | I5 Conical | I5 Conical | Lance |
| K Number | K051719 | K051719 | K040807 |
| PlacementMethod | Dual-stepsurgery. Laterexposurerequired. | Dual-step surgery.Later exposurerequired. | Dual-step surgery. Laterexposure required. |
| Indicationfor Use | Used in softbone anddesigned toenable thechange ofdirection duringimplantation. | Used in soft boneand designed toenable the changeof direction duringimplantation. | Used in soft bone |
| Length | 8,10,11.5,13,16 | 8,10,11.5,13,16 | 10,11.5, 13,16 |
| Available | 3.2,3.75,4.2,4. | 3.2,3.75,4.2,4.5,5, | 3.75,4.2,5 |
| diameters(mm) | 5. | 6 | |
| IntegratedAbutment | No | No | No |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium alloy Ti-6Al-4V-ELI.Grade-5. | Titanium alloy. Grade-4. |
| ExternalSurface | Sandblasted andacid etchedsurface. (HA) | Sandblasted andacid etchedsurface (SLA). | Sandblasted and acid etchedsurface (SLA). |
| SelfTapping | Yes | Yes | Yes |
| AB Dental | AB Dental | M.I.S Implant Technologies | |
| ProductName | 17 Integral | One-piece 17 | UNO - ONE PIECE SCREW-TYPE |
| K Number | K051719 | K080162 | |
| PlacementMethod | Single-stepsurgery. Noexposurerequired. | Single-stepsurgery. Noexposure required. | Single-step surgery. No exposurerequired. |
| Indicationfor Use | For immediateloading. | For immediateloading. | For immediate loading. |
| Length | 10,11.5,13,16 | 10,11.5, 13,16 | 10,11.5, 13,16 |
| Availablediameters(mm) | 10,11.5,13,16 | 10,11.5, 13,16 | 3,3.5 |
| IntegratedAbutment | Yes | Yes | Yes |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium alloy Ti-6Al-4V-ELI.Grade-5. | Titanium alloy Ti-6Al-4V-ELI.Grade-5. |
| ExternalSurface | Sandblasted andacid etchedsurface. (HA) | Sandblasted andacid etchedsurface (SLA). | Sandblasted and acid etchedsurface (SLA). |
| SelfTapping | Yes | Yes | Yes |
| Pull outstrengthtest(Newtons) | 162.9N | 135.8N | |
| AB Dental | AB Dental |
الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع المو
୍ର ପ୍ରଶାସ
्र
{4}------------------------------------------------
다. 공장
| 波
ी करने के बाद में बाद में कि में बाद में कि में कि में कि में कि में कि में कि में कि में कि कहानी की कहानी की कहानी की कहानी की कहानी की कहानी की किसी है।
संस्कृत
मिली
{5}------------------------------------------------
| ProductName | 110 Trapeze | Nobel Active | Touareg WP5mmD |
|---|---|---|---|
| K Number | K102436 | K081751 | |
| PlacementMethod | Single-stepsurgery. Noexposurerequired. | Single-stepsurgery. Noexposure required. | Single-step surgery. No exposurerequired. |
| Indicationfor Use | Is suitable for allindications andoffersexceptionalprimary stability.Designed toenable thechange ofdirection duringimplantation. | Is suitable for allindications andoffers exceptionalprimary stability. | Is suitable for all indications. |
| Length | 8,10,11.5,13,16 | 8.5,10,11.5,13,16 | 8.5,10,11.5,13,15 |
| Availablediameters(mm) | 3.75, 4.2, 5 | 4.3,5 | 5 |
| IntegratedAbutment | No | No | No |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium | Titanium alloy Ti-6Al-4V-ELI. |
| ExternalSurface | Sandblasted andacid etchedsurface.(HA) | Anodized surface:partial crystallineand phosphateenriched titaniumOxide surface. | OsseoFix, Calcium phosphatetreated surface. |
| SelfTapping | Yes | Yes | Yes |
| ABUTMENTS | |||
| AB Dental | AB Dental | Biohorizon | |
| ProductName | P1-Non HexedAbutment | P1-Non HexedAbutment | Titanium Temporary AbutmentsNon-hexed |
| K Number | K051719 | K103691 | |
| Indicationfor Use | For connectingtwo or moreimplants byusing apermanent rod.For permanent | For connecting twoor more implantsby using apermanent rod.For permanent | Use for multiple-unit, screw-retained, long term temporaryrestorations (>30 days). |
| and finalrestoration. | restoration. | ||
| Dimensions | Diameter:3.75Length:9,13 | Diameter:3.75Length:9,13 | Diameter:3.5,4.5,5.7 Length:12 |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium alloy Ti-6Al-4V-ELI.Grade-5. | Titanium alloy |
| Angle | No | No | No |
| AB Dental | AB Dental | Biohorizon | |
| ProductName | P3 AbutmentAnti-rotation | P3 Abutment Anti-rotation | Internal Laser-Lok Abutment |
| K Number | K051719 | K103691 | |
| Indicationfor Use | When widespaces arerequired, forback teeth.When space islimited, betweentwo teeth orimplants at theanterior of themouth. For thickgums when theimplant is verydeep. | When wide spacesare required, forback teeth. Whenspace is limited,between two teethor implants at theanterior of themouth. For thickgums when theimplant is verydeep. | Designed to be placed at implantsurgery or uncover and remain inplace through final restoration. |
| Dimensions | Diameter3,3.75,5Length:5,7,9,12,15 | Diameter:3.75Length:5,7,9,12,15 | Diameter:3.5,4.5,5.7Length:4,5.5 |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium alloy Ti-6Al-4V-ELI.Grade-5. | Titanium Alloy. |
| Angle | No | No | No |
| AB Dental | AB Dental | Zimmer | |
| ProductName | P3S AnatomicAnti-rotation | P3S AnatomicAnti-rotation | Hex-Lock Contour Abutment |
| K Number | K051719 | K052600 | |
| Indicationfor Use | To follow thegum line. | To follow the gumline. | For limited interocclusalSpace. |
| Dimensions | Diameter:3.75CuffHeight:1,2,3. | Diameter:3.75 CuffHeight:2,3,4. | Diameter:3.5,4.5,5.7 CuffHeight:1,2,3. |
| Material | Titanium alloy Ti-Titanium Alloy. | ||
| Indicationfor Use | To be usedwhen space islimited, betweentwo teeth orimplants, usuallyat the anterior ofthe mouth. | To be used whenspace is limited,between two teethor implants,usually at theanterior of themouth. | To be used when space islimited, between two teeth orimplants, usually at the anterior ofthe mouth. |
| Dimensions | Diameter:3.75Length:5,7,9. | Diameter:3.75Length:5,7,9. | Diameter:3.75 Length:11 |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium alloy Ti-6Al-4V-ELI.Grade-5. | Titanium alloy |
| Angle | No | No | No |
| AB Dental | MIS | AlfaBio tec | |
| ProductName | P3W - Wideanti-rotationabutment | MD-WMAC1Wide cementingpost, SP | TLAW |
| K Number | K040807 | K063364 | |
| Indicationfor Use | To be usedwhen there is awide spacebetween twoteeth orimplants, usuallyat the posteriorpart of themouth | To be used whenthere is a widespace betweentwo teeth orimplants, usuallyat the posteriorpart of the mouth | To be used when there is a widespace between two teeth orimplants, usually at the posteriorpart of the mouth |
| Dimensions | Diameter: 3.75Length: 9, 12. | Diameter: 5.5Length:11 | Diameter: 4.5Length:9 |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium | Titanium |
| Angle | 0 | 0 | 0 |
| Ti-6Al-4V-ELI.Grade-5. | 6Al-4V-ELI.Grade-5. | ||
| Angle | No | No | No |
| ProductName | AB DentalP3N-NarrowAnti-rotationAbutment | AB DentalP3N-Narrow Anti-rotation Abutment | MISMN-MAC10Narrow platformcementino post. NP |
| Product Name | |||
| P12-3.75 - FlatConnectionAbutment | FC-6013,6018 | ||
| K Number | K081751 | ||
| Indicationfor Use | Abutment with aflat connectionfor screwretainedrestoration ontilted implants | Abutment with aflat connection forscrew retainedrestoration ontilted implants | |
| Dimensions | Diameter:4.5Length:5 | Diameter:4Length:5 | |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium alloy Ti-6Al-4V-ELI.Grade-5. | |
| Angle | 0 | 0 | |
| AB Dental | Adin | ||
| Product Name | P12-3.75-T -Temporary FlatConnectionAbutment | FC-6013,6018 | |
| K Number | K081751 | ||
| Indicationfor Use | Temporaryabutment with aflat connectionfor screwretainedrestoration ontilted implants | Abutment with aflat connection forscrew retainedrestoration ontilted implants | |
| Dimensions | Diameter:4.5Length:15 | Diameter:4Length:5 | |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5. | Titanium alloy Ti-6Al-4V-ELI.Grade-5. | |
| Angle | 0 | 0 | |
| AB Dental | Alpha-Bio Tec | ||
| Product Name | P15-3x -TemporaryAbutment forImmediateLoading | Straight TitaniumAbutmentsETLA | |
| K Number | K063364 | ||
| Indicationfor Use | Used for | Used for | |
| for Use | temporaryrestoration. | temporaryrestoration. | |
| Dimensions | Diameter:3, 3.75Length: 1,2,3,4,5,7 | Diameter:3.9,4.5Length: 7 | |
| Material | Titanium alloyTi-6Al-4V-ELI.Grade-5+plastic. | Titanium alloy Ti-6Al-4V-ELI.+plastic. | |
| Angle | 0 | 0 | |
| HEALING CAPS | |||
| AB Dental | Alpha Bio | ||
| ProductName | PO-P6H forAestheticAbutment withHex | HCT | |
| KNumber | K042654 | ||
| Indicationfor Use | Used to allow thegingiva to healaround P6Habutment | Used to allow thegingiva to healaround P6Habutment | |
| Dimensions | Diameter:4.7Length:5 | Diameter:4.7Length:5 | |
| Material | Titanium alloy Ti-6Al-4V-ELI.Grade-5 | Titanium alloy Ti-6Al-4V-ELI.Grade-5 | |
| AB Dental | Alpha Bio | Adin | |
| ProductName | PO-TitaniumHealing Cap | HS | WP-0046,0047,0048,0049,0050 |
| KNumber | K042654 | K081751 | |
| Indicationfor Use | Used to allow thegingiva to healaround implants | Used to allow thegingiva to healaround implants | Used to allow the gingiva to healaround implants |
| Dimensions | Diameter:3.75Length:2,3,4,5,6,7 | Diameter:4.5Length:2,3,4,5,6,7 | Diameter:4Length:2,3,4,5,6 |
| Material | Titanium alloy Ti-6Al-4V-ELI.Grade-5 | Titanium | Titanium alloy Ti-6Al-4V-ELI.Grade-5 |
| ADAPTORS | |||
| AB Dental | MIS | ||
| ProductName | P16-Straightadaptor | Pilier Multi Unit | |
| KNumber | K040807 | ||
| Indicationfor Use | Used for screwretainedrestoration | Used fortemporaryrestoration | |
| Dimensions | Diameter:3.0,3.75Length: 1,2,3,4,5. | Diameter:3.75Length: 1,2,3,4 | |
| Material | Titanium alloy Ti-6Al-4V-ELI.Grade-5 | Titanium alloy Ti-6Al-4V-ELI. |
ళ్ళు
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{6}------------------------------------------------
న్నాయ
{7}------------------------------------------------
9
September 19, 10, 10, 10,
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{8}------------------------------------------------
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{9}------------------------------------------------
{10}------------------------------------------------
יל איני מיני .
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Contractor Comments
િત્ત્વ
ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤ ﻟﻠﻘﺎﻧﻮﻥ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
ಿಗಳು
ವಿಧಾರವಾಗಿ ಪ್ರಮ : ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮ
{11}------------------------------------------------
Brief Discussion of the Non-Clinical Tests Submitted
As part of demonstrating safety and effectiveness of AB Dental dental implants and in showing substantial equivalence to the predicate devices that are the subject of this 51 0(k) submission, AB Dental submitted a selected number of its dental implants for fatigue testing in accordance with ISO 14801, Dentistry -Implants - Dynamic Fatigue Test for Endosseous Dental Implants. Further, AB Dental dental implants also underwent extensive SEM surface analysis and surface topography studies to prove that the blasting and postblasting surface cleaning process used during the manufacture of these devices produced implants that resulted in a clean, textured, surface. In addition, the 17 implants were subjected to pullout testing.
Clinical Testing
No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.
Conclusions
We believe that the AB Dental Implants products, which are the subject of this submission are substantially equivalent predicate devices cited. The device constitutes a safe, reliable and effective medical device, meeting all declared requirements of its intended use and the device does not introduce new risks and does not present any adverse health effects or safety risks to patients when used as intended.
{12}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
A.B. Dental Devices, LTD C/O Charles Hurwitz, Ph.D. MedicSense LTD POB 367 Ramat Hasharon ISRAEL 47103
APR 1 8 2012
Re: K112440
Trade/Device Name: AB Dental Devices Implants and Accessories Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 10, 2012 Received: April 13, 2012
Dear Dr. Hurwitz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
· Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (k) Number K112440
Device Name: AB Dental Dental Devices Implants and Accessories
Indications For Use :
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The AB Dental Devices implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
17 Integral implant, 15 Conical implant, P15 Temporary abutment, P12-T,L Temporary flat connection abutment, and P16 Straight adaptor are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use ( 21CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE(
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Susan Quare
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K160446
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.