FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
9.6% HYDROFLUORIC ACID GEL
K Number: K896655
·
Decision Feb 14, 1990
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
410
Applicant Total
78
Review Days
82
Basic Information
- Device Name
- 9.6% HYDROFLUORIC ACID GEL
- K Number
- K896655
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- PULPDENT CORP.
- Date Received
- November 24, 1989
- Decision Date
- February 14, 1990
- 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.
HF-Etchant Hydrofluoric Acid Etching Gel
FDA 510(k)
FDA Class 2
·Dental
TopCEM Ceramic Primer Ceramic Coupling Agent
FDA 510(k)
FDA Class 2
·Dental
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
FDA 510(k)
FDA Class 2
·Dental
Ceramic Etchant (HF-5 and HF-9)
FDA 510(k)
FDA Class 2
·Dental
K-Bond Universal
FDA 510(k)
FDA Class 2
·Dental
Light Cure Adhesive
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by PULPDENT CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K014138 | PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT | Mar 14, 2002 | Substantially Equivalent |
| K014133 | PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE | Mar 14, 2002 | Substantially Equivalent |
| K020115 | PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM | Feb 28, 2002 | Substantially Equivalent |
| K014059 | PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE | Feb 27, 2002 | Substantially Equivalent |
| K013411 | PULPDENT CAVITY PREPARATION IV | Dec 12, 2001 | Substantially Equivalent |
| K994180 | PULPDENT CAVITY PREPARATION III | Mar 2, 2000 | Substantially Equivalent |
| K994181 | PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE | Feb 29, 2000 | Substantially Equivalent |
| K994182 | PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE | Feb 23, 2000 | Substantially Equivalent |
| K993683 | PULPDENT UNO-DUO | Dec 13, 1999 | Substantially Equivalent |
| K974202 | PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS | Mar 19, 1998 | Substantially Equivalent |