(238 days)
Not Found
No
The summary describes dental implants and abutments, focusing on their mechanical properties and intended use for supporting prosthetics. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.
Yes
The device is described as "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" and "restore esthetics and chewing functions," indicating it directly treats or rehabilitates a medical condition.
No
The device is an implant designed for surgical placement to support crowns, bridges, or overdentures, which are restorative functions, not diagnostic ones.
No
The device description and performance studies clearly indicate this is a physical dental implant system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for surgical placement in the mouth to support dental prosthetics. This is a surgical and restorative procedure performed directly on a patient's body.
- Device Description: The description reinforces that the implants are designed to support prosthetic devices for restoring esthetics and chewing functions. This is a mechanical and structural function within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is implanted within the body.
N/A
Intended Use / 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.
Product codes
DZE, NHA
Device Description
AB Dental implants are designed to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing functions.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Tests:
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.
Key Metrics
Not Found
Predicate Device(s)
AB Dental 12, screw type, K051719, M.I.S Implant Technologies, Bio-Com, K040807, AB Dental, I5 Conical, K051719, M.I.S Implant Technologies, Lance, K040807, AB Dental, I7 One-piece, K051719, M.I.S Implant Technologies, Uno one piece screw type, K080162, Nobel Biocare, Nobel Active, K102436, ADIN, Touareg WP5mmD, K081751, AB Dental, P1-Non Hexed Abutment, K051719, Biohorizon, Titanium Temporary Abutments - Non-hexed, K103691, AB Dental, P3 Abutment Anti-rotation, K051719, Biohorizon, Internal Laser-Lok Abutment, K103691, AB Dental, P3 Narrow Abutment Anti-rotation, K051719, MIS, MN-MAC10, Narrow platform cementing post, NP, K040807, MIS, MD-WMAC1 Wide cementing post, SP, K040807, AlfaBio tec, TLAW, K063364, AlfaBio tec, TLABG, K063364, MIS, MG-GPC10 Direct gold plastic cylinder with hex. Internal hex, K063364, Adin, FC-6013,6018, K081751, Alpha-Bio Tec, Straight Titanium Abutments ETLA, K063364, Alpha Bio, HCT, K042654, Alpha Bio, HS, K042654, Adin, WP-0046,0047,0048,0049,0050, K081751, MIS, Pilier Multi Unit, K040807
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, Uno | |
| one piece screw type, K080162 | ||
| I10 Trapeze | Nobel Biocare, Nobel Active, | |
| K102436 | ADIN, Touareg WP5mmD, | |
| K081751 | ||
| P1-Non Hexed Abutment | AB Dental, P1-Non Hexed | |
| Abutment, K051719 | Biohorizon, Titanium Temporary | |
| Abutments - Non-hexed, | ||
| K103691 | ||
| P3 Abutment Anti-rotation | AB Dental, P3 Abutment Anti- | |
| rotation, K051719 | Biohorizon, Internal Laser-Lok | |
| Abutment, K103691 | ||
| P3N-Narrow Anti-rotation | ||
| Abutment | AB Dental, P3 Narrow Abutment | |
| Anti-rotation, K051719 | MIS, MN-MAC10, Narrow | |
| platform cementing post, NP, | ||
| K040807 | ||
| P3W - Wide anti-rotation | ||
| abutment | MIS, MD-WMAC1 Wide | |
| cementing post, SP, K040807 | AlfaBio tec, TLAW, K063364 | |
| P3W - Wide anti-rotation | ||
| abutment | MIS, MD-WMAC1 Wide | |
| cementing post, SP, K040807 | AlfaBio tec, TLAW, K063364 | |
| P9HG-3.75,11 Gold Composed | ||
| Hex Abutment | AlfaBio tec, TLABG, K063364 | MIS, MG-GPC10 Direct gold |
| plastic cylinder with hex. Internal | ||
| hex, K063364 | ||
| P12-3.75 - Flat Connection | ||
| Abutment | Adin, FC-6013,6018, K081751 | |
| P12-3.75-T - Temporary Flat | ||
| Connection Abutment | Adin, FC-6013,6018, K081751 | |
| P15-3x - Temporary Abutment | ||
| for Immediate Loading | Alpha-Bio Tec, Straight Titanium | |
| Abutments ETLA, K063364 | ||
| PO-P6H for Aesthetic Abutment | ||
| with 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 |
| Product | |||
| Name | I2 Screw Type | I2 Screw Type | Bio-Com |
| K Number | K051719 | K051719 | K040807 |
| Placement | |||
| Method | Dual-step | ||
| surgery. Later | |||
| exposure | |||
| required. | Dual-step surgery. | ||
| Later exposure | |||
| required. | Dual-step surgery. Later | ||
| exposure required. | |||
| Indication | |||
| for Use | For use in dense | ||
| bone | For use in dense | ||
| bone | 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 | ||
| Available | |||
| diameters | |||
| (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 | ||
| Integrated | |||
| Abutment | No | No | No |
| Material | Titanium alloy | ||
| Ti-6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy. Grade-4. | ||
| External | |||
| Surface | Sandblasted and | ||
| acid etched | |||
| surface . (HA) | Sandblasted and | ||
| acid etched | |||
| surface (SLA). | Sandblasted and acid etched | ||
| surface (SLA). | |||
| Self | |||
| Tapping | Yes | Yes | Yes |
| AB Dental | AB Dental | M.I.S Implant Technologies | |
| Product | |||
| Name | I5 Conical | I5 Conical | Lance |
| K Number | K051719 | K051719 | K040807 |
| Placement | |||
| Method | Dual-step | ||
| surgery. Later | |||
| exposure | |||
| required. | Dual-step surgery. | ||
| Later exposure | |||
| required. | Dual-step surgery. Later | ||
| exposure required. | |||
| Indication | |||
| for Use | Used in soft | ||
| bone and | |||
| designed to | |||
| enable the | |||
| change of | |||
| direction during | |||
| implantation. | Used in soft bone | ||
| and designed to | |||
| enable the change | |||
| of direction during | |||
| implantation. | 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 | |
| Integrated | |||
| Abutment | No | No | No |
| Material | Titanium alloy | ||
| Ti-6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy. Grade-4. | ||
| External | |||
| Surface | Sandblasted and | ||
| acid etched | |||
| surface. (HA) | Sandblasted and | ||
| acid etched | |||
| surface (SLA). | Sandblasted and acid etched | ||
| surface (SLA). | |||
| Self | |||
| Tapping | Yes | Yes | Yes |
| AB Dental | AB Dental | M.I.S Implant Technologies | |
| Product | |||
| Name | 17 Integral | One-piece 17 | UNO - ONE PIECE SCREW- |
| TYPE | |||
| K Number | K051719 | K080162 | |
| Placement | |||
| Method | Single-step | ||
| surgery. No | |||
| exposure | |||
| required. | Single-step | ||
| surgery. No | |||
| exposure required. | Single-step surgery. No exposure | ||
| required. | |||
| Indication | |||
| for Use | For immediate | ||
| loading. | For immediate | ||
| loading. | For immediate loading. | ||
| Length | 10,11.5,13,16 | 10,11.5, 13,16 | 10,11.5, 13,16 |
| Available | |||
| diameters | |||
| (mm) | 10,11.5,13,16 | 10,11.5, 13,16 | 3,3.5 |
| Integrated | |||
| Abutment | Yes | Yes | Yes |
| Material | Titanium alloy | ||
| Ti-6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy Ti-6Al-4V-ELI. | ||
| Grade-5. | |||
| External | |||
| Surface | Sandblasted and | ||
| acid etched | |||
| surface. (HA) | Sandblasted and | ||
| acid etched | |||
| surface (SLA). | Sandblasted and acid etched | ||
| surface (SLA). | |||
| Self | |||
| Tapping | Yes | Yes | Yes |
| Pull out | |||
| strength | |||
| test | |||
| (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
| Product
| Name | 110 Trapeze | Nobel Active | Touareg WP5mmD |
|---|---|---|---|
| K Number | K102436 | K081751 | |
| Placement | |||
| Method | Single-step | ||
| surgery. No | |||
| exposure | |||
| required. | Single-step | ||
| surgery. No | |||
| exposure required. | Single-step surgery. No exposure | ||
| required. | |||
| Indication | |||
| for Use | Is suitable for all | ||
| indications and | |||
| offers | |||
| exceptional | |||
| primary stability. | |||
| Designed to | |||
| enable the | |||
| change of | |||
| direction during | |||
| implantation. | Is suitable for all | ||
| indications and | |||
| offers exceptional | |||
| primary 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 |
| Available | |||
| diameters | |||
| (mm) | 3.75, 4.2, 5 | 4.3,5 | 5 |
| Integrated | |||
| Abutment | No | No | No |
| Material | Titanium alloy | ||
| Ti-6Al-4V-ELI. | |||
| Grade-5. | Titanium | Titanium alloy Ti-6Al-4V-ELI. | |
| External | |||
| Surface | Sandblasted and | ||
| acid etched | |||
| surface.(HA) | Anodized surface: | ||
| partial crystalline | |||
| and phosphate | |||
| enriched titanium | |||
| Oxide surface. | OsseoFix, Calcium phosphate | ||
| treated surface. | |||
| Self | |||
| Tapping | Yes | Yes | Yes |
| ABUTMENTS | |||
| AB Dental | AB Dental | Biohorizon | |
| Product | |||
| Name | P1-Non Hexed | ||
| Abutment | P1-Non Hexed | ||
| Abutment | Titanium Temporary Abutments | ||
| Non-hexed | |||
| K Number | K051719 | K103691 | |
| Indication | |||
| for Use | For connecting | ||
| two or more | |||
| implants by | |||
| using a | |||
| permanent rod. | |||
| For permanent | For connecting two | ||
| or more implants | |||
| by using a | |||
| permanent rod. | |||
| For permanent | Use for multiple-unit, screw- | ||
| retained, long term temporary | |||
| restorations (>30 days). | |||
| and final | |||
| restoration. | restoration. | ||
| Dimensions | Diameter:3.75 | ||
| Length:9,13 | Diameter:3.75 | ||
| Length:9,13 | Diameter:3.5,4.5,5.7 Length:12 | ||
| Material | Titanium alloy | ||
| Ti-6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy | ||
| Angle | No | No | No |
| AB Dental | AB Dental | Biohorizon | |
| Product | |||
| Name | P3 Abutment | ||
| Anti-rotation | P3 Abutment Anti- | ||
| rotation | Internal Laser-Lok Abutment | ||
| K Number | K051719 | K103691 | |
| Indication | |||
| for Use | When wide | ||
| spaces are | |||
| required, for | |||
| back teeth. | |||
| When space is | |||
| limited, between | |||
| two teeth or | |||
| implants at the | |||
| anterior of the | |||
| mouth. For thick | |||
| gums when the | |||
| implant is very | |||
| deep. | When wide spaces | ||
| are required, for | |||
| back teeth. When | |||
| space is limited, | |||
| between two teeth | |||
| or implants at the | |||
| anterior of the | |||
| mouth. For thick | |||
| gums when the | |||
| implant is very | |||
| deep. | Designed to be placed at implant | ||
| surgery or uncover and remain in | |||
| place through final restoration. | |||
| Dimensions | Diameter3,3.75, | ||
| 5 | |||
| Length:5,7,9,12, | |||
| 15 | Diameter:3.75 | ||
| Length:5,7,9,12,15 | Diameter:3.5,4.5,5.7Length:4,5.5 | ||
| Material | Titanium alloy | ||
| Ti-6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| Grade-5. | Titanium Alloy. | ||
| Angle | No | No | No |
| AB Dental | AB Dental | Zimmer | |
| Product | |||
| Name | P3S Anatomic | ||
| Anti-rotation | P3S Anatomic | ||
| Anti-rotation | Hex-Lock Contour Abutment | ||
| K Number | K051719 | K052600 | |
| Indication | |||
| for Use | To follow the | ||
| gum line. | To follow the gum | ||
| line. | For limited interocclusal | ||
| Space. | |||
| Dimensions | Diameter:3.75 | ||
| Cuff | |||
| Height:1,2,3. | Diameter:3.75 Cuff | ||
| Height:2,3,4. | Diameter:3.5,4.5,5.7 Cuff | ||
| Height:1,2,3. | |||
| Material | Titanium alloy Ti- | ||
| Titanium Alloy. | |||
| Indication | |||
| for Use | To be used | ||
| when space is | |||
| limited, between | |||
| two teeth or | |||
| implants, usually | |||
| at the anterior of | |||
| the mouth. | To be used when | ||
| space is limited, | |||
| between two teeth | |||
| or implants, | |||
| usually at the | |||
| anterior of the | |||
| mouth. | To be used when space is | ||
| limited, between two teeth or | |||
| implants, usually at the anterior of | |||
| the mouth. | |||
| Dimensions | Diameter:3.75 | ||
| Length:5,7,9. | Diameter:3.75 | ||
| Length:5,7,9. | Diameter:3.75 Length:11 | ||
| Material | Titanium alloy | ||
| Ti-6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| Grade-5. | Titanium alloy | ||
| Angle | No | No | No |
| AB Dental | MIS | AlfaBio tec | |
| Product | |||
| Name | P3W - Wide | ||
| anti-rotation | |||
| abutment | MD-WMAC1 | ||
| Wide cementing | |||
| post, SP | TLAW | ||
| K Number | K040807 | K063364 | |
| Indication | |||
| for Use | To be used | ||
| when there is a | |||
| wide space | |||
| between two | |||
| teeth or | |||
| implants, usually | |||
| at the posterior | |||
| part of the | |||
| mouth | To be used when | ||
| there is a wide | |||
| space between | |||
| two teeth or | |||
| implants, usually | |||
| at the posterior | |||
| part of the mouth | To be used when there is a wide | ||
| space between two teeth or | |||
| implants, usually at the posterior | |||
| part of the mouth | |||
| Dimensions | Diameter: 3.75 | ||
| Length: 9, 12. | Diameter: 5.5 | ||
| Length:11 | Diameter: 4.5 | ||
| Length:9 | |||
| Material | Titanium alloy | ||
| Ti-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 |
| Product | |||
| Name | AB Dental | ||
| P3N-Narrow | |||
| Anti-rotation | |||
| Abutment | AB Dental | ||
| P3N-Narrow Anti- | |||
| rotation Abutment | MIS | ||
| MN-MAC10 | |||
| Narrow platform | |||
| cementino post. NP | |||
| Product Name | |||
| P12-3.75 - Flat | |||
| Connection | |||
| Abutment | FC-6013,6018 | ||
| K Number | K081751 | ||
| Indication | |||
| for Use | Abutment with a | ||
| flat connection | |||
| for screw | |||
| retained | |||
| restoration on | |||
| tilted implants | Abutment with a | ||
| flat connection for | |||
| screw retained | |||
| restoration on | |||
| tilted implants | |||
| Dimensions | Diameter:4.5 | ||
| Length:5 | Diameter:4 | ||
| Length:5 | |||
| Material | Titanium alloy | ||
| Ti-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 Flat | |||
| Connection | |||
| Abutment | FC-6013,6018 | ||
| K Number | K081751 | ||
| Indication | |||
| for Use | Temporary | ||
| abutment with a | |||
| flat connection | |||
| for screw | |||
| retained | |||
| restoration on | |||
| tilted implants | Abutment with a | ||
| flat connection for | |||
| screw retained | |||
| restoration on | |||
| tilted implants | |||
| Dimensions | Diameter:4.5 | ||
| Length:15 | Diameter:4 | ||
| Length:5 | |||
| Material | Titanium alloy | ||
| Ti-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 - | ||
| Temporary | |||
| Abutment for | |||
| Immediate | |||
| Loading | Straight Titanium | ||
| Abutments | |||
| ETLA | |||
| K Number | K063364 | ||
| Indication | |||
| for Use | Used for | Used for | |
| for Use | temporary | ||
| restoration. | temporary | ||
| restoration. | |||
| Dimension | |||
| s | Diameter:3, 3.75 | ||
| Length: 1,2,3,4,5 | |||
| ,7 | Diameter:3.9,4.5 | ||
| Length: 7 | |||
| Material | Titanium alloy | ||
| Ti-6Al-4V-ELI. | |||
| Grade-5+plastic. | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| +plastic. | |||
| Angle | 0 | 0 | |
| HEALING CAPS | |||
| AB Dental | Alpha Bio | ||
| Product | |||
| Name | PO-P6H for | ||
| Aesthetic | |||
| Abutment with | |||
| Hex | HCT | ||
| K | |||
| Number | K042654 | ||
| Indication | |||
| for Use | Used to allow the | ||
| gingiva to heal | |||
| around P6H | |||
| abutment | Used to allow the | ||
| gingiva to heal | |||
| around P6H | |||
| abutment | |||
| Dimensio | |||
| ns | Diameter:4.7 | ||
| Length:5 | Diameter:4.7 | ||
| Length:5 | |||
| Material | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| Grade-5 | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| Grade-5 | |||
| AB Dental | Alpha Bio | Adin | |
| Product | |||
| Name | PO-Titanium | ||
| Healing Cap | HS | WP-0046,0047,0048,0049,0050 | |
| K | |||
| Number | K042654 | K081751 | |
| Indication | |||
| for Use | Used to allow the | ||
| gingiva to heal | |||
| around implants | Used to allow the | ||
| gingiva to heal | |||
| around implants | Used to allow the gingiva to heal | ||
| around implants | |||
| Dimensio | |||
| ns | Diameter:3.75 | ||
| Length:2,3,4,5, | |||
| 6,7 | Diameter:4.5 | ||
| Length:2,3,4,5,6,7 | Diameter:4 | ||
| Length: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 | ||
| Product | |||
| Name | P16-Straight | ||
| adaptor | Pilier Multi Unit | ||
| K | |||
| Number | K040807 | ||
| Indication | |||
| for Use | Used for screw | ||
| retained | |||
| restoration | Used for | ||
| temporary | |||
| restoration | |||
| Dimensions | Diameter:3.0,3.75 | ||
| Length: 1,2,3,4,5. | Diameter:3.75 | ||
| Length: 1,2,3,4 | |||
| Material | Titanium alloy Ti- | ||
| 6Al-4V-ELI. | |||
| Grade-5 | Titanium alloy Ti- | ||
| 6Al-4V-ELI. |
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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.
13
Page 2 - Dr. Hurwitz
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
14
Indications for Use
510 (k) Number K112440
Device Name: AB Dental Dental Devices Implants and Accessories
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.
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(
Page 1 of 1
Susan Quare
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K160446