FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BEAUTIBOND MULTI
K Number: K110235
·
Decision May 13, 2011
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
59
Review Days
107
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Basic Information
- Device Name
- BEAUTIBOND MULTI
- K Number
- K110235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shofu Dental Corp.
- Date Received
- January 26, 2011
- Decision Date
- May 13, 2011
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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Other Clearances by Shofu Dental Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K111855 | HY-BOND RESIGLASS | Nov 17, 2011 | Substantially Equivalent |
| K110252 | BEAUTIBOND MULTI PR PLUS | May 13, 2011 | Substantially Equivalent |
| K101603 | BEAUTIFIL FLOW PLUS | Aug 23, 2010 | Substantially Equivalent |
| K101621 | LITE ART | Aug 23, 2010 | Substantially Equivalent |
| K093559 | VINTAGE MP | Mar 3, 2010 | Substantially Equivalent |
| K082744 | BEAUTIBOND | Dec 11, 2008 | Substantially Equivalent |
| K080517 | RESICEM | Jun 11, 2008 | Substantially Equivalent |
| K080834 | VINTAGE ART | Jun 11, 2008 | Substantially Equivalent |
| K080068 | BEAUTIFIL OPAQUER | Feb 28, 2008 | Substantially Equivalent |
| K071742 | BEAUTIFIL II | Aug 15, 2007 | Substantially Equivalent |