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Global D 118 Avenue Marcel Merieux Zone Industrielle de Sacuny 69530 Brignais
CRO : Lyon B 752 283 739
SASU with capital of 1 116 536€
Phone : +33 (0)4 78 56 97 00
E-mail : email@example.com
15 Rue de Chavril
SAS with capital de 86 853 €
RCS paris : 481 681 724
Headquarters : 5 rue de la Terrasse – 75017 Paris – France
Phone : 01 80 05 97 30
Christophe Marrone – firstname.lastname@example.org
Damien Ferrandis – email@example.com
Manufacturer: GLOBAL D
118 Avenue Marcel Mérieux
Tel : +33 (0)4 78 56 97 00
Fax : +33 (0)4 78 56 01 63
SAS with capital of 1 116 536€
SIRET No. : 752 283 739 000 23
Address : 118 avenue Marcel Mérieux 96530 Brignais –France
ISO 13485 and ISO 9001 certification given by LNE/GMED (0459)
Materials: all implants are made of titanium alloy (TA6V) or pure titanium (T40, T60) in accordance with ISO 5832-3 and ISO 5832-2.
Claimed indications for use:
- Dental implant systems : Serf and Tekka dental implant systems consist of endo-osseous implants, instrumentation and associated prosthesis components. Serf and Tekka dental implants must be inserted surgically into the bone of the upper or lower jaw to support prosthetic devices and restore the patient’s esthetics and chewing ability, in single unit or multi-unit applications. Tekka products KRESTAL®, KRESTAL®Universal, In-Kone®Universal, T-QUEST®Universal and SERF products EVL® N, EVL® S, EVL® KONIK , CLINIC® E, CLINIC® K can be used either in a one-stage or two-stage surgical procedure, while Tekka products Twinkon®Universal, PROGRESS and MONOBLOC and SERF products INCYBLOC®, INCYBLOC® L, EVL® COMPACT were designed for one-stage procedures. Immediate loading is recommended if good primary stability and appropriate occlusal loading are present. This technique should only be used when other less invasive therapies are not as appropriate.
- Maxillofacial fixation system : Tekka maxillofacial fixation systems are intended for osteotomy, stabilization and rigid fixation of CMF (craniomaxillofacial) fractures and also for reconstructive and orthognathic surgery..
- The ORTRAUTEK and EASYTEK® ortrau systems consist of plates and screws:
• The ORTRAUTEK TRAUMA system is a craniomaxillofacial system composed of titanium screws and plates intended for stabilization and rigid fixation of craniomaxillofacial fractures, limited trauma and reconstructive surgery.
• The ORTRAUTEK ORTHOGNATHIC system is intended for oral maxillofacial surgery and selected orthognathic surgery of the maxilla and mandible..
- The MINITEK, MICROTEK, EASYTEK®mini and EASYTEK®micro systems are used in pediatric trauma case and trauma of the mid-face to stabilize craniofacial skeleton fractures..
- The GRAFTEK and EASYTEK®graft systems are used to insert bone grafts and attach membranes during pre-implant surgery.
- The NEUROTEK and EASYTEK®neuro systems are used to close cranial bone flaps and in cases of trauma to the upper third of the craniofacial skeleton requiring fixation.
- The Tekka CARCITEK and EASYTEK®carci mandibular reconstruction system are used for internal fixation of mandibular fractures, along with primary and secondary reconstruction.
- The Tekka ANCOTEK and EASYTEK®anco orthodontic anchoring systems are used for bone fixation during orthodontics aiming to reposition one or many teeth.
- Use of the described fixation and anchoring systems can only be considered when all less invasive medical and surgical options have been determined to be not as appropriate.
Refer to the instruction leaflet included in each package.
Caution: all these components can be exported if current approvals have been obtained for the countries in question.