Who is the manufacturer of AB DENTAL DEVICES IMPLANTS AND ACCESSORIES?

A.B. Dental Devices , Ltd. filed the 510(k) submission for AB DENTAL DEVICES IMPLANTS AND ACCESSORIES (K112440).

What is the FDA product code for AB DENTAL DEVICES IMPLANTS AND ACCESSORIES?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for AB DENTAL DEVICES IMPLANTS AND ACCESSORIES?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AB DENTAL DEVICES IMPLANTS AND ACCESSORIES?

AB Dental I2, 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 (K040807); MIS, MD-WMAC1 Wide cementing post (K040807); AlfaBio tec, TLAW (K063364); AlfaBio tec, TLABG (K063364); MIS, MG-GPC10 Direct gold plastic cylinder (K063364); Adin, FC-6013,6018 (K081751); Alpha-Bio Tec, Straight Titanium Abutments ETLA (K063364); Alpha Bio, HCT (K042654); Alpha Bio, HS (K042654); MIS, Pilier Multi Unit (K040807).

Who can help prepare an FDA 510(k) submission like AB DENTAL DEVICES IMPLANTS AND ACCESSORIES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AB DENTAL DEVICES IMPLANTS AND ACCESSORIES

K112440 · A.B. Dental Devices , Ltd. · DZE · Apr 18, 2012 · Dental

Device Facts

Record ID	K112440
Device Name	AB DENTAL DEVICES IMPLANTS AND ACCESSORIES
Applicant	A.B. Dental Devices , Ltd.
Product Code	DZE · Dental
Decision Date	Apr 18, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

AB Dental implants and accessories are endosseous dental devices used to restore esthetics and chewing function in edentulous or partially edentulous patients. The system includes various screw-type and conical implants, abutments, healing caps, and adaptors. Implants are surgically placed into the maxillary or mandibular bone. The device functions as a mechanical support structure for prosthetic restorations (crowns, bridges, overdentures). Some components support immediate loading protocols when primary stability is achieved. The devices are used in clinical dental settings by trained dental professionals. The system utilizes titanium alloy (Ti-6Al-4V-ELI) and features sandblasted and acid-etched surface treatments to facilitate osseointegration. The output is a stable foundation for dental prosthetics, which benefits the patient by restoring oral function and appearance.

Clinical Evidence

No clinical testing was performed. Safety and effectiveness were established through non-clinical bench testing, including dynamic fatigue testing per ISO 14801 and pull-out strength testing. Surface characteristics were verified via SEM analysis.

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V-ELI (Grade 5). Surface: Sandblasted and acid-etched. Design: Endosseous dental implants, abutments, and accessories. Mechanical: Self-tapping threads. Sterilization: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for edentulous or partially edentulous patients requiring surgical placement of dental implants in the maxillary or mandibular arch to support crowns, bridges, or overdentures. Specific components are indicated for immediate loading given sufficient primary stability and appropriate occlusal loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

AB Dental I2, 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 (K040807)
MIS, MD-WMAC1 Wide cementing post (K040807)
AlfaBio tec, TLAW (K063364)
AlfaBio tec, TLABG (K063364)
MIS, MG-GPC10 Direct gold plastic cylinder (K063364)
Adin, FC-6013,6018 (K081751)
Alpha-Bio Tec, Straight Titanium Abutments ETLA (K063364)
Alpha Bio, HCT (K042654)
Alpha Bio, HS (K042654)
MIS, Pilier Multi Unit (K040807)

Submission Summary (Full Text)

{0}------------------------------------------------ K112440 # 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. | | ళ్ళు all and the collection of the state of the starter of the start {6}------------------------------------------------ న్నాయ {7}------------------------------------------------ 9 September 19, 10, 10, 10, . 100 {8}------------------------------------------------ : {9}------------------------------------------------ {10}------------------------------------------------ יל איני מיני . (අබ 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

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