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510(k) Data Aggregation
K Number
K173706Device Name
Piccolo Implants and Accessories
Manufacturer
Southern Implants (Pty) Ltd.
Date Cleared
2018-06-08
(186 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Southern Implants (Pty) Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Piccolo Implants and Accessories are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
• replacing maxillary lateral incisors and mandibular incisors,
• immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
• immediate loading when good primary stability with appropriate occlusal loading is achieved, except in soft bone (type IV) where implant stability may be difficult to obtain.
Device Description
The Piccolo Implants and Accessories is a threaded root-form dental implant and abutment system.
The implants are Ø3.0 mm in diameter with lengths of 8.5, 10, 11.5, 13 and 15 mm. There is a standard version and a MSC version with a 1 and 3 mm machined surface coronal region respectively. The rest of the body has a roughened surface. The system has an external hexagonal implant-abutment interface.
The following abutments are included in the range: Cover Screws, Healing Abutments (all made from commercially pure titanium (CPTi)), Gold Abutments (made from gold alloy), Passive Abutments and Compact Conical Abutments (both made from titanium alloy). All abutments (except the onepiece abutments) are used with a titanium alloy retaining screw.
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K Number
K161548Device Name
Osseointegrated Fixtures
Manufacturer
SOUTHERN IMPLANTS (PTY) LTD.
Date Cleared
2016-12-01
(181 days)
Product Code
FZE
Regulation Number
878.3680Why did this record match?
Applicant Name (Manufacturer) :
SOUTHERN IMPLANTS (PTY) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Southern Implants Osseointegrated Fixtures are indicated for the attachment of an external on prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are in the maxillo-craniofacial region (including ear, nose and eye).
Device Description
The device 'Osseointegrated Fixtures' refers to a system involving endosseous implants and their accessories. The endosseous implants are solid, screw-type, self-tapping implants made from commercially pure titanium, with the same enhanced surface as the Southern Implants dental implants. The accessories include drills to prepare the site, abutments and attachments to aid the prosthetic retention, placement tools, instruments and laboratory components.
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