FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESTIC MICROFILL
K Number: K780833
·
Decision Jun 14, 1978
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
25
Review Days
23
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ESTIC MICROFILL
- K Number
- K780833
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Degussa Dental, Inc.
- Date Received
- May 22, 1978
- Decision Date
- June 14, 1978
- Product Code
- EBF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.
SRGC-06
FDA 510(k)
FDA Class 2
·Dental
DIAFIL
FDA 510(k)
FDA Class 2
·Dental
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
FDA 510(k)
FDA Class 2
·Dental
Dual Core
FDA 510(k)
FDA Class 2
·Dental
Dura-Crown
FDA 510(k)
FDA Class 2
·Dental
Grandio disc multicolor
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Degussa Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883758 | ALBABOND 60 | Oct 12, 1988 | Substantially Equivalent |
| K883511 | ALBABOND E | Oct 6, 1988 | Substantially Equivalent |
| K883508 | HERA H | Sep 22, 1988 | Substantially Equivalent |
| K883509 | HERAEUS DG 63 | Sep 22, 1988 | Substantially Equivalent |
| K883510 | DEGUPAL 4 | Sep 15, 1988 | Substantially Equivalent |
| K883507 | HERAEUS C SPECIAL | Sep 15, 1988 | Substantially Equivalent |
| K883512 | HERAEUS WHITE | Sep 6, 1988 | Substantially Equivalent |
| K883036 | PALLIAG NF III | Aug 12, 1988 | Substantially Equivalent |
| K880033 | DEGUSTAR | Mar 7, 1988 | Substantially Equivalent |
| K871808 | DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM | Jun 5, 1987 | Substantially Equivalent |