FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
K Number: K042466
·
Decision Nov 24, 2004
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
14
Review Days
72
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Basic Information
- Device Name
- X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
- K Number
- K042466
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zest Anchors, Inc.
- Date Received
- September 13, 2004
- Decision Date
- November 24, 2004
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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|---|---|---|---|
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| K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | Dec 3, 2007 | Substantially Equivalent |
| K033699 | LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 | Apr 22, 2004 | Substantially Equivalent |
| K994257 | LOCATOR IMPLANT ANCHOR | Mar 17, 2000 | Substantially Equivalent |
| K925849 | ZEST IMPLANT ANCHOR | Nov 18, 1994 | Substantially Equivalent |
| K934668 | ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL) | Jun 22, 1994 | Substantially Equivalent |
| K925700 | ZEST ANCHOR ADVANCED GENERATION | Apr 7, 1994 | Substantially Equivalent |
| K882063 | MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER | Jun 13, 1988 | Substantially Equivalent |
| K861561 | ZEST MARK II (STANDARD & MINI) | May 21, 1986 | Substantially Equivalent |