The five IFU indications
AmGraft® is intended to fill and/or augment bony voids or gaps in dentoalveolar surgery. The IFU recommends it for five clinical uses.
Professional reference
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Alveolar ridge IFU
Augmentation or reconstructive treatment of the alveolar ridge
AmGraft® IFU, recommended clinical uses
Before use, the IFU asks the clinician to:
- confirm that general oral surgery is not contraindicated, for example by infection at the grafting site;
- take special caution with diseases or therapies that adversely affect healing (listed under Precautions);
- prepare the graft bed by removing bone fragments, granulation and necrotic tissue;
- allow a minimum of 6 months’ healing at the augmented site, with the final timing decided by the practitioner.
AmGraft® is not intended to bear mechanical loads.
After root resection, apicoectomy, cystectomy IFU
Filling of alveolar bone defects after root resection, apicoectomy, and cystectomy
AmGraft® IFU, recommended clinical uses
Before use, the IFU asks the clinician to:
- confirm that general oral surgery is not contraindicated, for example by infection at the grafting site;
- take special caution with diseases or therapies that adversely affect healing (listed under Precautions);
- prepare the graft bed by removing bone fragments, granulation and necrotic tissue;
- allow a minimum of 6 months’ healing at the augmented site, with the final timing decided by the practitioner.
AmGraft® is not intended to bear mechanical loads.
Following extraction IFU
Filling of alveolar defects following dental extraction
AmGraft® IFU, recommended clinical uses
Before use, the IFU asks the clinician to:
- confirm that general oral surgery is not contraindicated, for example by infection at the grafting site;
- take special caution with diseases or therapies that adversely affect healing (listed under Precautions);
- prepare the graft bed by removing bone fragments, granulation and necrotic tissue;
- allow a minimum of 6 months’ healing at the augmented site, with the final timing decided by the practitioner.
AmGraft® is not intended to bear mechanical loads.
Periodontal defects IFU
Filling of periodontal alveolar bone defects
AmGraft® IFU, recommended clinical uses
Before use, the IFU asks the clinician to:
- confirm that general oral surgery is not contraindicated, for example by infection at the grafting site;
- take special caution with diseases or therapies that adversely affect healing (listed under Precautions);
- prepare the graft bed by removing bone fragments, granulation and necrotic tissue;
- allow a minimum of 6 months’ healing at the augmented site, with the final timing decided by the practitioner.
AmGraft® is not intended to bear mechanical loads.
Peri-implant defects IFU
Filling of peri-implant alveolar bone defects
AmGraft® IFU, recommended clinical uses
Before use, the IFU asks the clinician to:
- confirm that general oral surgery is not contraindicated, for example by infection at the grafting site;
- take special caution with diseases or therapies that adversely affect healing (listed under Precautions);
- prepare the graft bed by removing bone fragments, granulation and necrotic tissue;
- allow a minimum of 6 months’ healing at the augmented site, with the final timing decided by the practitioner.
AmGraft® is not intended to bear mechanical loads.
Only these five clinical uses appear in the IFU. Other uses are not listed.