FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
LUTE; CORE
K Number: K011517
·
Decision Jul 10, 2001
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
5
Review Days
54
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Basic Information
- Device Name
- LUTE; CORE
- K Number
- K011517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- First Scientific Limited
- Date Received
- May 17, 2001
- Decision Date
- July 10, 2001
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by First Scientific Limited
| K Number | Device Name | ||
|---|---|---|---|
| K011521 | ORTHO VLC; ORTHO VLC CAPSULE | Aug 1, 2001 | Substantially Equivalent |
| K011520 | RESTORE-X | Jul 23, 2001 | Substantially Equivalent |
| K011295 | RESTORE-PF VIC; RESTORE-PF VLC CAPSULE | Jun 27, 2001 | Substantially Equivalent |
| K011309 | LUTE VLC; CORE VLC | Jun 22, 2001 | Substantially Equivalent |