FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM
K Number: K930248
·
Decision Jan 7, 1994
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
18
Review Days
353
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Basic Information
- Device Name
- VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM
- K Number
- K930248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Crown Delta Corp.
- Date Received
- January 19, 1993
- Decision Date
- January 7, 1994
- 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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| K901991 | SILICONE ELASTOMER PUTTY | Sep 14, 1990 | Substantially Equivalent |
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| K872745 | VINYL POLYSILOXANE IMPRESSION SYSTEM | Jul 21, 1987 | Substantially Equivalent |
| K871409 | VINYL POLYSILOXANE IMPRESSION SYSTEM | Jun 11, 1987 | Substantially Equivalent |
| K843145 | TWO COMPONENT RTV VINYL SILICONE MATER | Oct 18, 1984 | Substantially Equivalent |