FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRAFILL- ULTRABOUND
K Number: K781345
·
Decision Aug 31, 1978
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
51
Applicant Total
4
Review Days
24
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Basic Information
- Device Name
- ULTRAFILL- ULTRABOUND
- K Number
- K781345
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3310
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Demetron Research Corp.
- Date Received
- August 7, 1978
- Decision Date
- August 31, 1978
- Product Code
- EBD
- 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 |
|---|---|---|---|
| EBD | Coating, Filling Material, Resin | FDA class 2 | Dental |
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