FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLTENE COLTEX/COLTOFLAX
K Number: K811666
·
Decision Jul 15, 1981
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
13
Review Days
30
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Basic Information
- Device Name
- COLTENE COLTEX/COLTOFLAX
- K Number
- K811666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Coltene, Inc.
- Date Received
- June 15, 1981
- Decision Date
- July 15, 1981
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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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 |
| K863998 | COLTENE JET-MIXER | Oct 30, 1986 | 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 |