FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NMF004A
K Number: K173500
·
Decision Mar 8, 2018
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
127
Review Days
115
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
- NMF004A
- K Number
- K173500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GC America, Inc.
- Date Received
- November 13, 2017
- Decision Date
- March 8, 2018
- 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 GC America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261246 | SRGC-06 | Jun 18, 2026 | Substantially Equivalent |
| K254109 | G-CEM UNIVERSAL | May 18, 2026 | Substantially Equivalent |
| K251124 | G-Bond Universal | Oct 2, 2025 | Substantially Equivalent |
| K250953 | EQUIA LC ONE | Sep 19, 2025 | Substantially Equivalent |
| K251946 | G aenial Universal Injectable II | Aug 29, 2025 | Substantially Equivalent |
| K200798 | G-CEM ONE | Nov 24, 2020 | Substantially Equivalent |
| K200682 | BZF-29 | Oct 2, 2020 | Substantially Equivalent |
| K192597 | Cytrans Granules | Aug 17, 2020 | Substantially Equivalent |
| K193113 | GC Temp Print | Jul 9, 2020 | Substantially Equivalent |
| K193484 | GC Fuji Triage EP | Jul 2, 2020 | Substantially Equivalent |