510(k) K770872
- Device
- IMPRESSION MATERIAL, ALGINATE
- Applicant
- Espe GmbH (Us)
- 510(k) number
- K770872
- Product code
- ELN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-01
- Date received
- 1977-05-13
- Regulation
- 872.3580
- Classification name
- Teeth, Preformed Gold Denture
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3017903664
- 3038290056
- 3005621362
- 3020052762
- 3023248501
Source Documents#
510(k) summary PDF not indicated by FDA