FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Denture Base
K Number: K260376
·
Decision May 6, 2026
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
9
Review Days
90
Basic Information
- Device Name
- Denture Base
- K Number
- K260376
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shandong Huge Dental Material Corporation
- Date Received
- February 5, 2026
- Decision Date
- May 6, 2026
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBI), ordered by most recent decision date.
DB 4000 High Impact Denture Base
FDA 510(k)
FDA Class 2
·Dental
LuxCreo Flexible Partial Denture Resin
FDA 510(k)
FDA Class 2
·Dental
TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
FDA 510(k)
FDA Class 2
·Dental
UltraPrint-Dental Denture UV
FDA 510(k)
FDA Class 2
·Dental
Freeprint® denture flex
FDA 510(k)
FDA Class 2
·Dental
DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Shandong Huge Dental Material Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K260067 | Eternal Art Porcelain Powders | Apr 9, 2026 | Substantially Equivalent |
| K251252 | NOBILCAM IMPAK Disc | Aug 1, 2025 | Substantially Equivalent |
| K220680 | Denture Base Polymers | Aug 12, 2022 | Substantially Equivalent |
| K213994 | Flexible Block | Mar 4, 2022 | Substantially Equivalent |
| K201684 | A-Silicone for Bite Registration | Sep 24, 2020 | Substantially Equivalent |
| K181747 | Orthodontic Appliance | Apr 18, 2019 | Substantially Equivalent |
| K160345 | Glass Ionomer Cement | Mar 3, 2017 | Substantially Equivalent |
| K161851 | Glass Ionomer Cement (Luting) | Oct 31, 2016 | Substantially Equivalent |