FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALGINATE IMPRESSION MATERIAL
K Number: K771938
·
Decision Nov 2, 1977
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
14
Review Days
16
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Basic Information
- Device Name
- ALGINATE IMPRESSION MATERIAL
- K Number
- K771938
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- The S. S. White Co.
- Date Received
- October 17, 1977
- Decision Date
- November 2, 1977
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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Other Clearances by The S. S. White Co.
| K Number | Device Name | ||
|---|---|---|---|
| K852745 | PORCELAIN VENEER SYSTEM BONDING KIT | Aug 16, 1985 | Substantially Equivalent |
| K852744 | CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR | 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 |
| K781293 | RESTORATIVE SYSTEM PROFILE | Aug 18, 1978 | Substantially Equivalent |
| K770093 | DENTAL BURS | Jan 24, 1977 | Substantially Equivalent |
| K760369 | POWDERLITE | Aug 11, 1976 | Substantially Equivalent |