FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250
K Number: K001309
·
Decision Jun 13, 2000
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
5
Review Days
49
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Basic Information
- Device Name
- HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250
- K Number
- K001309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kay See Dental Mfg. Co.
- Date Received
- April 25, 2000
- Decision Date
- June 13, 2000
- 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 Kay See Dental Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | Sep 22, 1999 | Substantially Equivalent |
| K991161 | HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 | Apr 29, 1999 | Substantially Equivalent |
| K990306 | HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 | Mar 3, 1999 | Substantially Equivalent |
| K990155 | HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 | Feb 25, 1999 | Substantially Equivalent |