FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BZF-29
K Number: K200682
·
Decision Oct 2, 2020
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
127
Review Days
200
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
- BZF-29
- K Number
- K200682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GC America, Inc.
- Date Received
- March 16, 2020
- Decision Date
- October 2, 2020
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLE), ordered by most recent decision date.
Any-Etch
FDA 510(k)
FDA Class 2
·Dental
Porcelain Etch Gel
FDA 510(k)
FDA Class 2
·Dental
Adhese 2
FDA 510(k)
FDA Class 2
·Dental
Bond-PR Universal Adhesive
FDA 510(k)
FDA Class 2
·Dental
VITA VMLC Primer
FDA 510(k)
FDA Class 2
·Dental
els unibond
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 |
| 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 |
| K192260 | everX Flow | Nov 22, 2019 | Substantially Equivalent |