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510(k) Data Aggregation
K Number
K181381Device Name
A.B. Dental Devices Dental Implants System
Manufacturer
A.B Dental Device Ltd.
Date Cleared
2018-11-23
(183 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
A.B Dental Device Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:
- . P0-3 narrow platform healing caps, 4 and 7 mm length
- PON-3.75 standard platform, narrow healing caps, 4 and 7 mm length .
- P3-5 standard platform, straight abutment, 5 mm diameter, 5 mm length ●
- P3S-3 narrow platform, anatomic, straight abutment, 1, 2, 3 mm shoulder lengths
- . P3SW-3.75 standard platform, anatomic, straight abutment, wide diameter, 1, 2, 3 mm shoulder lengths
- P3W-3 narrow platform, straight abutment, wide diameter, 9 mm length
- P5-3 narrow platform, ball attachment, 4, 5, 6 mm height
- P5-3.75-20 standard platform, 20º ball attachment, 4 and 6 mm height ●
- P9HG-3.75 standard platform, composed abutment, gold alloy
- P9R and P9HR -3.75 standard platform, composed abutment, CoCr alloy
- . P25-3 narrow platform, A.B. LOC abutments, 0, 1, 2, 3, 4 5 mm height
- . P25-3.75 standard platform. A.B. LOC abutments. 0. 1. 2 mm height
- . P64-3.75 standard platform, straight adaptor abutment, 1, 2, 3, 4, 5 mm heights
- P64 plastic and Ti alloy sleeve
- P64 healing cap ●
- PK standard platform, anatomic anti-rotation abutment, 1, 2, 3, 4 mm height
- PK plastic sleeve
- . PK healing cap
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