FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RESIN TRAY IMPRESSION MATERIAL
K Number: K854042
·
Decision Nov 7, 1985
Classifications
1
FEI Numbers
187
Registration Numbers
187
Same Product Code
29
Applicant Total
279
Review Days
36
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Basic Information
- Device Name
- RESIN TRAY IMPRESSION MATERIAL
- K Number
- K854042
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3670
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Dentsply Intl.
- Date Received
- October 2, 1985
- Decision Date
- November 7, 1985
- Product Code
- EBH
- 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 |
|---|---|---|---|
| EBH | Material, Impression Tray, Resin | FDA class 1 | Dental |
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