← FDA Medical Device Classifications
Sterilizer, Glass Bead
ECC · Class III — High Risk (PMA approval required, life-sustaining) · Dental · 21 CFR 872.6730
Classification
- FDA Product Code
ECC- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 872.6730
- Review panel
- DE
- Medical specialty
- Dental
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Call for PMAs on 4/21/97 per 62 FR 2902 on 1/27/97
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown