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K Number
K150363Device Name
NOVA Dental Implants System
Manufacturer
Date Cleared
2015-06-29
(137 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NOVA Implants Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NOVA® 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. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
NOVA® Dental Implants System consists of internal hex dental implants. cover screws and healing caps; abutments system and superstructures; impression copy system & surgical instruments.
Internal hex implants:-
PSI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
PCI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
NOVA Dental Abutments internal hex system provides:
Healing Caps:
HC Series - Narrow (3.75 mm) - Platform height 2,3,4,5,6,7
HC Series - Standard (4.7 mm) - Platform height 2.3.4.5.6.7
HCW Series - Wide (6.00 mm) - Platform height 3,4,5,6
PMI Series - Premium (3.75, 4.7, 6.0 mm) - Platform height 2,3,4,5,6,7
Straight Abutments (Long, straight, narrow, anatomic, curve):
ST Series: Length 8.5, 9.5, 11.5, 12.5 mm.
STA Series: With Shoulder profile height 1, Length 9 mm; profile height 2, Length 10; profile height 3, Length 11; profile height 4 Length 12.
STN: Narrow length 11 mm.
SLM Series: Anatomic Straight Abutment: profile height 1,2,3 length 9,10,11 mm.
SCM Series: Anatomic Straight Abutment: profile height 1.2.3 length 9.10.11 mm.
Angulated Abutments (standard, anatomic, curve):
Standard Angulated Abutment Length 7,9,11 Angulations 15°, 25°.
Anatomic Angulated Abutments Platform height 1,2,3,4 Angulations 15°, 25°.
Anatomic Angulated Curve Platform height 1,2,3, Angulations 15°, 25° .
Ball Attachments Platform height 1.2.3.4.5.6 and related components covers and caps.
Material:
NOVA® Dental Implants System and Dental Abutments System is made of Titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
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