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510(k) Data Aggregation
K Number
K211551Device Name
Wishbone HA
Manufacturer
Wishbone SA
Date Cleared
2021-08-20
(93 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Wishbone SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wishbone HA is intended for the following uses:
· Filling of infrabony periodontal defects;
· Filling of periodontal defects in conjunction with products intended for guided tissue regeneration and guided bone regeneration:
· Filling of defects after root resection, apicectomy and cystectomy;
- · Filling of extraction sockets to enhance preservation of the alveolar ridge;
- · Augmentation or reconstructive treatment of the alveolar ridge;
- · Elevation of the maxillary sinus floor;
· Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.
Device Description
Wishbone HA is a xenograft biomaterial composed of deproteinized hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.
Wishbone HA is supplied as a mix of cancellous and cortical particles size 0.25 to 1.0 mm) in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
The device is intended to be used in medical procedures, by a qualified physician (academically trained dentists, periodontists and oral surgeons).
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