FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRADENT PORCELAIN ETCH
K Number: K951582
·
Decision May 10, 1995
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
103
Review Days
34
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ULTRADENT PORCELAIN ETCH
- K Number
- K951582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ultradent Products, Inc.
- Date Received
- April 6, 1995
- Decision Date
- May 10, 1995
- 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.
Rosetta SM, Rosetta SP
FDA 510(k)
FDA Class 2
·Dental
DCMhotbond zircon
FDA 510(k)
FDA Class 2
·Dental
Eternal Art Porcelain Powders
FDA 510(k)
FDA Class 2
·Dental
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
FDA 510(k)
FDA Class 2
·Dental
IPS e.max Zirconia
FDA 510(k)
FDA Class 2
·Dental
BruxZir® Shaded 16 PLUS
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Ultradent Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261404 | UltraEZ | Apr 30, 2026 | Substantially Equivalent |
| K240743 | Peak Universal Bond | Mar 20, 2024 | Substantially Equivalent |
| K240694 | FORMA Composite (Shade A3D) | Mar 15, 2024 | Substantially Equivalent |
| K221909 | J-Temp | Jul 1, 2022 | Substantially Equivalent |
| K220471 | VALO X, VALO X Accessory Lenses | Feb 22, 2022 | Substantially Equivalent |
| K211905 | UltraCal XS | Oct 13, 2021 | Substantially Equivalent |
| K211237 | UltraTemp Rez II | Jul 13, 2021 | Substantially Equivalent |
| K210550 | VALO Grand Corded and Accessory Lenses | Mar 1, 2021 | Substantially Equivalent |
| K190627 | VALO Grand Corded | Apr 29, 2019 | Substantially Equivalent |
| K173163 | ChlorCid, ChlorCid V, ChlorCid Surf | Feb 9, 2018 | Substantially Equivalent |