FDA 510(k) K080445, LION SE ONE STEP ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc.
FDA 510(k) K080445, LION SE ONE STEP ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc.
FDA 510(k) records for LION SE ONE STEP ORTHODONTIC ADHESIVE (K080445), submitted by Classone Orthodontics, Inc..
- 510(k) Number: K080445
- Applicant: Classone Orthodontics, Inc.
- Decision Date: 07/16/2008
- Decision: Substantially Equivalent (SESE)
- Product Code: DYH DYH
- Review Panel: Dental
- Total PDF Pages: 102
- Fully Redacted Pages: 28
- Usable Pages: 74
Sections Included
- 510(k) Summary: pages 1-10; 0.0% redacted (Unredacted)
- CDRH Premarket Review Submission Cover Sheet: pages 11; 0.0% redacted (Unredacted)
- Sterilization: pages 12-21; 10.0% redacted (Minimal Redaction)
- Indications for Use: pages 22-35; 64.3% redacted (Heavy Redaction)
- Device Description: pages 36-58; 56.5% redacted (Heavy Redaction)
- Indications for Use: pages 59; 0.0% redacted (Unredacted)
- Device Description: pages 60-102; 11.6% redacted (Moderate Redaction)
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