FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WILDE ADHESIVE BONDING SYSTEM
K Number: K913581
·
Decision Feb 26, 1993
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
16
Review Days
564
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Basic Information
- Device Name
- WILDE ADHESIVE BONDING SYSTEM
- K Number
- K913581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wilde-USA, Inc.
- Date Received
- August 12, 1991
- Decision Date
- February 26, 1993
- 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 Wilde-USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913582 | COMPATIT R | Jun 24, 1993 | Substantially Equivalent |
| K915653 | KERAMAIL | Apr 8, 1993 | Substantially Equivalent |
| K923472 | COMPACOLOR | Oct 13, 1992 | Substantially Equivalent |
| K920649 | COMPASEP | Jul 23, 1992 | Substantially Equivalent |
| K913089 | WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS | Apr 21, 1992 | Substantially Equivalent |
| K915250 | WIL-PDS & WIL-PDI CASTING ALLOYS | Apr 21, 1992 | Substantially Equivalent |
| K912990 | CONVERBASE | Mar 25, 1992 | Substantially Equivalent |
| K920557 | WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX | Mar 20, 1992 | Substantially Equivalent |
| K915654 | KERALLOY-D CAPS | Mar 2, 1992 | Substantially Equivalent |
| K912993 | WILDE DENTURE RESINS | Feb 3, 1992 | Substantially Equivalent |