FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NU-CAP CALCIUM HYDROX. PULP CAPPING
K Number: K831575
·
Decision Jun 30, 1983
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
76
Applicant Total
20
Review Days
45
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Basic Information
- Device Name
- NU-CAP CALCIUM HYDROX. PULP CAPPING
- K Number
- K831575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Coe Laboratories, Inc.
- Date Received
- May 16, 1983
- Decision Date
- June 30, 1983
- Product Code
- EJK
- 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 |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | FDA class 2 | Dental |
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| K Number | Device Name | ||
|---|---|---|---|
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| K885010 | TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING | Feb 13, 1989 | Substantially Equivalent |
| K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET | Oct 31, 1988 | Substantially Equivalent |
| K881091 | OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL | Jun 28, 1988 | Substantially Equivalent |
| K863882 | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE | Nov 18, 1986 | Substantially Equivalent |
| K842877 | ABSOLUTE VINYL POLYSILOXANE IMPRESS | Mar 11, 1985 | Substantially Equivalent |
| K844325 | COE-LITE POLYMERIZATION UNIT | Dec 11, 1984 | Substantially Equivalent |