FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JEL BIOS 18 (CODE NAME RD- 1214)
K Number: K993152
·
Decision Oct 21, 1999
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
55
Review Days
30
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
- JEL BIOS 18 (CODE NAME RD- 1214)
- K Number
- K993152
- 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
- September 21, 1999
- Decision Date
- October 21, 1999
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJT), ordered by most recent decision date.
PROMETAL HN86
FDA 510(k)
FDA Class 2
·Dental
BIO 60
FDA 510(k)
FDA Class 2
·Dental
PORTA REFLEX
FDA 510(k)
FDA Class 2
·Dental
PORTA SOLDER 1090 W
FDA 510(k)
FDA Class 2
·Dental
NDX-40 ALLOY
FDA 510(k)
FDA Class 2
·Dental
HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
FDA 510(k)
FDA Class 2
·Dental
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 |
| K002222 | RD-2104 | Aug 31, 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 |
| K991564 | JELTEMP | Jun 23, 1999 | Substantially Equivalent |