FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RD-2104
K Number: K002222
·
Decision Aug 31, 2000
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
55
Review Days
38
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Basic Information
- Device Name
- RD-2104
- K Number
- K002222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J.F. Jelenko & Co., Inc.
- Date Received
- July 24, 2000
- Decision Date
- August 31, 2000
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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Other Clearances by J.F. Jelenko & Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012303 | JEL-20 | Aug 22, 2001 | Substantially Equivalent |
| K002993 | HERACERAM | Nov 16, 2000 | Substantially Equivalent |
| K002645 | JEL BIOS PURE | Oct 19, 2000 | Substantially Equivalent |
| K001360 | SIGNUM | Jun 20, 2000 | Substantially Equivalent |
| K001260 | ALLROUND 55 LF | May 17, 2000 | Substantially Equivalent |
| K001196 | JEL BIOS 90 (CODE NAME RD-2401) | May 11, 2000 | Substantially Equivalent |
| K000532 | JEL 15 | Apr 6, 2000 | Substantially Equivalent |
| K993136 | JEL BIOS 10 (CODE NAME RD-1801) | Oct 21, 1999 | Substantially Equivalent |
| K993152 | JEL BIOS 18 (CODE NAME RD- 1214) | Oct 21, 1999 | Substantially Equivalent |
| K991564 | JELTEMP | Jun 23, 1999 | Substantially Equivalent |