FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
K Number: K153067
·
Decision Jul 27, 2016
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
15
Review Days
279
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Basic Information
- Device Name
- Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
- K Number
- K153067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sybron Dental Specialties
- Date Received
- October 22, 2015
- Decision Date
- July 27, 2016
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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