FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ELIPAR TRILIGHT
K Number: K984247
·
Decision Feb 25, 1999
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
29
Review Days
90
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Basic Information
- Device Name
- ELIPAR TRILIGHT
- K Number
- K984247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Espe Dental AG
- Date Received
- November 27, 1998
- Decision Date
- February 25, 1999
- Product Code
- EBZ
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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| K Number | Device Name | ||
|---|---|---|---|
| K011394 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | Jun 29, 2001 | Substantially Equivalent |
| K011154 | ELIPAR FREELIGHT | May 16, 2001 | Substantially Equivalent |
| K002793 | KETAC CEM U | Sep 26, 2000 | Substantially Equivalent |
| K002364 | PROTEMP H | Aug 10, 2000 | Substantially Equivalent |
| K001494 | MODIFICATION TO PROMPT L-POP | Jul 7, 2000 | Substantially Equivalent |
| K000595 | DIMENSION PENTA L | Apr 5, 2000 | Substantially Equivalent |
| K000588 | DIMENSION GARANT L, DIMENSION GARANT L QUICK | Mar 30, 2000 | Substantially Equivalent |
| K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK | Mar 30, 2000 | Substantially Equivalent |
| K994193 | IMPREGUM PENTA DUOSOFT | Jan 28, 2000 | Substantially Equivalent |
| K994192 | IMPREGUM PENTA M MONOSOFT | Jan 28, 2000 | Substantially Equivalent |