FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HELIOSIT
K Number: K802683
·
Decision Nov 24, 1980
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
17
Review Days
27
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Basic Information
- Device Name
- HELIOSIT
- K Number
- K802683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Vivadent (Usa), Inc.
- Date Received
- October 28, 1980
- Decision Date
- November 24, 1980
- 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 |
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Other Clearances by Vivadent (Usa), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863831 | VIVADENT FILPIN | Oct 14, 1986 | Substantially Equivalent |
| K823409 | HELIOSIT-ORTHODONTIC | Jan 21, 1983 | Substantially Equivalent |
| K813015 | HELIOSEAL | Dec 2, 1981 | Substantially Equivalent |
| K802679 | SILANIT | Dec 17, 1980 | Substantially Equivalent |
| K802682 | CONTACT SEAL | Nov 24, 1980 | Substantially Equivalent |
| K802681 | HELIOBOND | Nov 24, 1980 | Substantially Equivalent |
| K802684 | HELIOMAT | Nov 24, 1980 | Substantially Equivalent |
| K802685 | REOLIT | Nov 12, 1980 | Substantially Equivalent |
| K802680 | ISOPAST-DS | Nov 12, 1980 | Substantially Equivalent |
| K801227 | SILICAP | Aug 12, 1980 | Substantially Equivalent |