Table 3.

Results of biological safety evaluation in accordance with the ISO 10993 series.

Evaluation Item	Ti–15–4	Ti–15–4–1	Ti–15–4–4
1. Cytotoxicity Colony formation	Medium extract: noncytotoxic	Medium extract: noncytotoxic	Direct contact: noncytotoxic
2. Sensitization	Accelerated extract: negative	Accelerated extract: negative	0.9%NaCl extract: negative
3. Irritation Intracutaneous reactivity	Accelerated extract: negative 0.9%NaCl extract: negative	0.9%NaCl extract: negative
4. Systemic toxicity (a) Acute systemic toxicity (b) Subacute systemic toxicity	Accelerated extract: nontoxic 0.9%NaCl extract: nontoxic 0.9%NaCl extract: nontoxic	0.9%NaCl extract: nontoxic 0.9%NaCl extract: nontoxic
5. Genotoxicity (a) Reverse mutation (b) Chromosomal abnormality	Accelerated extract: negative Medium extract: negative	0.9%NaCl extract: negative Medium extract: negative	0.9%NaCl extract: negative Medium extract: negative
6. Implantation	No inflammation in local implanted region, bone conductivity equivalent to control specimen	No inflammation in local implanted region, bone conductivity equivalent to control specimen	No inflammation in local implanted region, bone conductivity equivalent to control specimen