FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BruxZir Anterior Milling Blanks
K Number: K150872
·
Decision Jul 2, 2015
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
471
Applicant Total
26
Review Days
92
Basic Information
- Device Name
- BruxZir Anterior Milling Blanks
- K Number
- K150872
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PRISMATIK DENTALCRAFT, INC.
- Date Received
- April 1, 2015
- Decision Date
- July 2, 2015
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EIH), ordered by most recent decision date.
ARENA Star, Galaxy Star
FDA 510(k)
FDA Class 2
·Dental
Multi M Series
FDA 510(k)
FDA Class 2
·Dental
zirkon; structure; LFU shades, stains and glazes
FDA 510(k)
FDA Class 2
·Dental
CERABIEN MiLai
FDA 510(k)
FDA Class 2
·Dental
Biomic Color Opaque
FDA 510(k)
FDA Class 2
·Dental
ZircaGlow & ZircaGlow HT Zirconia
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by PRISMATIK DENTALCRAFT, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | Jun 6, 2017 | Substantially Equivalent |
| K162537 | CAD/CAMouflage Milling Block | Nov 16, 2016 | Substantially Equivalent |
| K160979 | Inclusive Abutments | Nov 4, 2016 | Substantially Equivalent |
| K153099 | INCLUSIVE TAPERED IMPLANT SYSTEM | May 23, 2016 | Substantially Equivalent |
| K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | Nov 16, 2015 | Substantially Equivalent |
| K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | Oct 7, 2015 | Substantially Equivalent |
| K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants | Oct 1, 2015 | Substantially Equivalent |
| K143353 | Hahn Tapered Implant System | Apr 2, 2015 | Substantially Equivalent |
| K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | Jan 6, 2015 | Substantially Equivalent |
| K143330 | BruxZir Anterior | Dec 15, 2014 | Substantially Equivalent |