FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K Number: K980800
·
Decision Nov 9, 1998
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
28
Review Days
252
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
- K Number
- K980800
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cosmedent, Inc.
- Date Received
- March 2, 1998
- Decision Date
- November 9, 1998
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.
SRGC-06
FDA 510(k)
FDA Class 2
·Dental
DIAFIL
FDA 510(k)
FDA Class 2
·Dental
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
FDA 510(k)
FDA Class 2
·Dental
Dual Core
FDA 510(k)
FDA Class 2
·Dental
Dura-Crown
FDA 510(k)
FDA Class 2
·Dental
Grandio disc multicolor
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Cosmedent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240714 | Insure® Universal; Insure® Universal Automix | Jul 24, 2024 | Substantially Equivalent |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | Oct 11, 2022 | Substantially Equivalent |
| K211259 | Renamel Bulkfill | Jun 24, 2021 | Substantially Equivalent |
| K172707 | Renamel Microfill | Dec 5, 2017 | Substantially Equivalent |
| K163480 | Renamel NANO +plus | Feb 24, 2017 | Substantially Equivalent |
| K092730 | COSMEDENT BRUSHABLE COMPOSITE | Nov 20, 2009 | Substantially Equivalent |
| K070583 | NANO COMPOSITE | Apr 16, 2007 | Substantially Equivalent |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | May 16, 2006 | Substantially Equivalent |
| K052263 | MULTIPLE (TOOTH DESENSITIZER) | Dec 16, 2005 | Substantially Equivalent |
| K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | Oct 21, 2005 | Substantially Equivalent |