FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Anchor plate
K Number: K173623
·
Decision Aug 30, 2018
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
51
Applicant Total
5
Review Days
279
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Basic Information
- Device Name
- Anchor plate
- K Number
- K173623
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomaterials Korea, Inc.
- Date Received
- November 24, 2017
- Decision Date
- August 30, 2018
- Product Code
- OAT
- 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 |
|---|---|---|---|
| OAT | Implant, Endosseous, Orthodontic | FDA class 2 | Dental |
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Other Clearances by Biomaterials Korea, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222245 | ACR Screw System | Aug 21, 2023 | Substantially Equivalent |
| K110926 | BONE PLATE; BONE SCREW | Dec 8, 2011 | Substantially Equivalent |
| K111809 | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS | Sep 26, 2011 | Substantially Equivalent |
| K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | Jul 26, 2007 | Substantially Equivalent |