FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENT-TEMP ACRYLIC
K Number: K972198
·
Decision Dec 17, 1997
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
8
Review Days
189
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Basic Information
- Device Name
- DENT-TEMP ACRYLIC
- K Number
- K972198
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Health-Dent Intl., Inc.
- Date Received
- June 11, 1997
- Decision Date
- December 17, 1997
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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Other Clearances by Health-Dent Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953405 | HEMA-BENZ | Sep 27, 1995 | Substantially Equivalent |
| K951220 | HEMA-GLU | May 12, 1995 | Substantially Equivalent |
| K951381 | VILA | Apr 27, 1995 | Substantially Equivalent |
| K951380 | VILA PC | Apr 27, 1995 | Substantially Equivalent |
| K951235 | GIROC | Apr 20, 1995 | Substantially Equivalent |
| K951236 | PRO-LOCK | Apr 18, 1995 | Substantially Equivalent |
| K951237 | ALGI-BAND | Apr 10, 1995 | Substantially Equivalent |