FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLTENE JET-MIXER
K Number: K863998
·
Decision Oct 30, 1986
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
12
Applicant Total
13
Review Days
16
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
- COLTENE JET-MIXER
- K Number
- K863998
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Coltene, Inc.
- Date Received
- October 14, 1986
- Decision Date
- October 30, 1986
- Product Code
- EID
- 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 |
|---|---|---|---|
| EID | Syringe, Restorative And Impression Material | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EID), ordered by most recent decision date.
BONE GRAFT DELIVERY SYRINGES
FDA 510(k)
FDA Class 1
·Dental
ACCESS IMPRESSION BARREL
FDA 510(k)
FDA Class 1
·Dental
CAULK'S VPS CARTRIDGE SYSTEM
FDA 510(k)
FDA Class 1
·Dental
IMPRESSION SYRINGE
FDA 510(k)
FDA Class 1
·Dental
CENTRIX RIBBON TUBES
FDA 510(k)
FDA Class 1
·Dental
UNITEK DISPOSABLE IMPRESSION SYRINGE
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Coltene, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902392 | COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL | Aug 28, 1990 | Substantially Equivalent |
| K882800 | COLTENE PRESIDENT JET REGULAR BODY | Sep 23, 1988 | Substantially Equivalent |
| K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM | Oct 27, 1987 | Substantially Equivalent |
| K870266 | COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM | Feb 27, 1987 | Substantially Equivalent |
| K870047 | COLTENE RAPID | Jan 29, 1987 | Substantially Equivalent |
| K850036 | COLTENE PRECISE | Feb 8, 1985 | Substantially Equivalent |
| K840297 | COLTENE ORALLOY MAGICAPS | Mar 16, 1984 | Substantially Equivalent |
| K811767 | COLTENE PRESIDENT IMPRESSION MATERIALS | Jul 15, 1981 | Substantially Equivalent |
| K811667 | COLTENE PRESSURE SPOT INDICATOR | Jul 15, 1981 | Substantially Equivalent |
| K811666 | COLTENE COLTEX/COLTOFLAX | Jul 15, 1981 | Substantially Equivalent |