FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BASE IT
K Number: K134022
·
Decision Jun 11, 2014
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
76
Applicant Total
17
Review Days
163
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
- BASE IT
- K Number
- K134022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spident Co., Ltd.
- Date Received
- December 30, 2013
- Decision Date
- June 11, 2014
- Product Code
- EJK
- 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 |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJK), ordered by most recent decision date.
Bright Cavity Liner
FDA 510(k)
FDA Class 2
·Dental
3M VitCal Liner/Base
FDA 510(k)
FDA Class 2
·Dental
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
FDA 510(k)
FDA Class 2
·Dental
CleaniCal
FDA 510(k)
FDA Class 2
·Dental
LC ResinCal PC
FDA 510(k)
FDA Class 2
·Dental
Parkell Desensitizer Gel
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Spident Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250566 | EsCem RMGI | Jun 20, 2025 | Substantially Equivalent |
| K250317 | EsFlow PLUS | May 30, 2025 | Substantially Equivalent |
| K242702 | VioSeal | Nov 7, 2024 | Substantially Equivalent |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Nov 1, 2024 | Substantially Equivalent |
| K241445 | K-Bond Universal | Jul 22, 2024 | Substantially Equivalent |
| K231523 | EsCom250 | Jul 24, 2023 | Substantially Equivalent |
| K214076 | EsCem | Dec 19, 2022 | Substantially Equivalent |
| K214071 | Hexa-Temp | Mar 10, 2022 | Substantially Equivalent |
| K161774 | i-Sil | Sep 30, 2016 | Substantially Equivalent |
| K134021 | ESTEMP IMPLANT, ESTEMP CLEAR | Jun 10, 2014 | Substantially Equivalent |