FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JEDENTAL PSROFILL SELF-CURE COMPOSITE
K Number: K933656
·
Decision Nov 17, 1993
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
8
Review Days
113
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Basic Information
- Device Name
- JEDENTAL PSROFILL SELF-CURE COMPOSITE
- K Number
- K933656
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jedental Co., Inc.
- Date Received
- July 27, 1993
- Decision Date
- November 17, 1993
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Jedental Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933612 | JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) | Feb 24, 1994 | Substantially Equivalent |
| K935718 | JEDENTAL VLC DENTAL CURING LIGHT | Jan 26, 1994 | Substantially Equivalent |
| K934073 | JEDENTAL GLASS IONOMER CEMENT AND LINER | Jan 26, 1994 | Substantially Equivalent |
| K935727 | P&FS PIT AND FISSURE SEALANT | Jan 21, 1994 | Substantially Equivalent |
| K933543 | ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) | Nov 1, 1993 | Substantially Equivalent |
| K933554 | JEDENTAL ZINC CEMENT IMPROVED | Nov 1, 1993 | Substantially Equivalent |
| K931880 | PROFILL LC COMPOSITE | Jul 8, 1993 | Substantially Equivalent |