IMPRESSION MATERIAL, ALGINATE
FDA 510(k) clearance K770872 · decided 1977-06-01
Clearance details
- K-number
- K770872
- Device name
- IMPRESSION MATERIAL, ALGINATE
- Applicant
- Espe GmbH (Us)
- Decision
- Substantially Equivalent
- Date received
- 1977-05-13
- Decision date
- 1977-06-01
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- ELN
- Device class
- 1
- Regulation number
- 872.3580
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.