FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS
K Number: K960595
·
Decision Apr 26, 1996
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
12
Review Days
74
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Basic Information
- Device Name
- FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS
- K Number
- K960595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dent Zar, Inc.
- Date Received
- February 12, 1996
- Decision Date
- April 26, 1996
- 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 Dent Zar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962277 | SELF CURE BONDING AGENT | Jul 3, 1996 | Substantially Equivalent |
| K960600 | LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS | Apr 26, 1996 | Substantially Equivalent |
| K960597 | ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE | Apr 26, 1996 | Substantially Equivalent |
| K960599 | SUPERIOR PHOTOCURING HYBRID COMPOSITE | Apr 26, 1996 | Substantially Equivalent |
| K960729 | ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) | Apr 26, 1996 | Substantially Equivalent |
| K960598 | CONCORD MARYLAND BRIDGE CEMENT | Apr 26, 1996 | Substantially Equivalent |
| K960594 | LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS | Apr 26, 1996 | Substantially Equivalent |
| K960596 | ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE | Apr 26, 1996 | Substantially Equivalent |
| K960565 | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | Mar 22, 1996 | Substantially Equivalent |
| K894639 | SKYROCK AND LIGHT SUPERBOND | Oct 20, 1989 | Substantially Equivalent |