FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM
K Number: K853005
·
Decision Aug 13, 1985
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
7
Applicant Total
14
Review Days
28
Basic Information
- Device Name
- S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM
- K Number
- K853005
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.1905
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- THE S. S. WHITE CO.
- Date Received
- July 16, 1985
- Decision Date
- August 13, 1985
- Product Code
- EGZ
- 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 |
|---|---|---|---|
| EGZ | Holder, Film, X-Ray | FDA class 1 | Dental |
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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 |
| 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 |
| K771938 | ALGINATE IMPRESSION MATERIAL | Nov 2, 1977 | Substantially Equivalent |
| K770093 | DENTAL BURS | Jan 24, 1977 | Substantially Equivalent |
| K760369 | POWDERLITE | Aug 11, 1976 | Substantially Equivalent |