FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESTORATIVE SYSTEM PROFILE
K Number: K781293
·
Decision Aug 18, 1978
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
913
Applicant Total
14
Review Days
22
Basic Information
- Device Name
- RESTORATIVE SYSTEM PROFILE
- K Number
- K781293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- THE S. S. WHITE CO.
- Date Received
- July 27, 1978
- Decision Date
- August 18, 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.
Once-Fil Flow
FDA 510(k)
FDA Class 2
·Dental
EsFlow PLUS
FDA 510(k)
FDA Class 2
·Dental
BEAUTIFIL II
FDA 510(k)
FDA Class 2
·Dental
Sil-Flow
FDA 510(k)
FDA Class 2
·Dental
GrandioSO Unlimited
FDA 510(k)
FDA Class 2
·Dental
Reon
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by THE S. S. WHITE CO.
| K Number | Device Name | ||
|---|---|---|---|
| K852744 | CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR | Aug 16, 1985 | Substantially Equivalent |
| K852745 | PORCELAIN VENEER SYSTEM BONDING KIT | Aug 16, 1985 | Substantially Equivalent |
| K853005 | S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM | Aug 13, 1985 | Substantially Equivalent |
| K852743 | PORCELAIN VENEER SYSTEM LABORATORY KIT | Jul 31, 1985 | Substantially Equivalent |
| K852182 | EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER | Jul 2, 1985 | Substantially Equivalent |
| K837440 | UNKNOWN | Jun 10, 1983 | Substantially Equivalent |
| K827816 | PODIATRY X-RAY UNIT | Aug 24, 1982 | Substantially Equivalent |
| K771938 | ALGINATE IMPRESSION MATERIAL | Nov 2, 1977 | Substantially Equivalent |
| K770093 | DENTAL BURS | Jan 24, 1977 | Substantially Equivalent |
| K760369 | POWDERLITE | Aug 11, 1976 | Substantially Equivalent |