FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOPACK NON-EUGENOL PERIODONTAL DRESSING
K Number: K913572
·
Decision Oct 9, 1991
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
495
Applicant Total
21
Review Days
58
Basic Information
- Device Name
- AUTOPACK NON-EUGENOL PERIODONTAL DRESSING
- K Number
- K913572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SPECIALITES SEPTODONT
- Date Received
- August 12, 1991
- Decision Date
- October 9, 1991
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMA), ordered by most recent decision date.
Choice 2 DC
FDA 510(k)
FDA Class 2
·Dental
ResiCem EX
FDA 510(k)
FDA Class 2
·Dental
EsCem RMGI
FDA 510(k)
FDA Class 2
·Dental
OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
FDA 510(k)
FDA Class 2
·Dental
Insure® Universal; Insure® Universal Automix
FDA 510(k)
FDA Class 2
·Dental
TopCEM-Veneer Light Cure Veneer Cement
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by SPECIALITES SEPTODONT
| K Number | Device Name | ||
|---|---|---|---|
| K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | Oct 9, 2001 | Substantially Equivalent |
| K010415 | ISODAN | Jul 23, 2001 | Substantially Equivalent |
| K982773 | QUICKSET LIQUID AND POWDER | Nov 3, 1998 | Substantially Equivalent |
| K982671 | SECURALLOY | Oct 19, 1998 | Substantially Equivalent |
| K980633 | ENDOSOLV E | May 1, 1998 | Substantially Equivalent |
| K920692 | SEPTOCALCINE ULTRA | Apr 21, 1992 | Substantially Equivalent |
| K915467 | CIMPAT S DENTAL CEMENT | Feb 3, 1992 | Substantially Equivalent |
| K915466 | SEPTOPACK TEMPORARY FILLING | Feb 3, 1992 | Substantially Equivalent |
| K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | Nov 7, 1991 | Substantially Equivalent |
| K913574 | SEPTOCAL CAVITY LINER | Sep 30, 1991 | Substantially Equivalent |