FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREMIUM
K Number: K011130
·
Decision Jul 5, 2001
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
54
Applicant Total
145
Review Days
83
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
- PREMIUM
- K Number
- K011130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3590
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- April 13, 2001
- Decision Date
- July 5, 2001
- Product Code
- ELM
- 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 |
|---|---|---|---|
| ELM | Denture, Plastic, Teeth | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELM), ordered by most recent decision date.
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
FDA 510(k)
FDA Class 2
·Dental
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
FDA 510(k)
FDA Class 2
·Dental
NEW STETIC ARTIFICIAL TEETH
FDA 510(k)
FDA Class 2
·Dental
PHYSIOSTAR NFC
FDA 510(k)
FDA Class 2
·Dental
VERACIA
FDA 510(k)
FDA Class 2
·Dental
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Heraeus Kulzer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091494 | FLEXITIME FLOW | Jul 31, 2009 | Substantially Equivalent |
| K063062 | HKBOND 2006 | Dec 1, 2006 | Substantially Equivalent |
| K060994 | MONDIAL | May 22, 2006 | Substantially Equivalent |
| K052543 | HERACERAM ZIRKONIA | Oct 25, 2005 | Substantially Equivalent |
| K043504 | PALAIMPACT | Jan 28, 2005 | Substantially Equivalent |
| K043295 | VERSYO.DIRECT | Jan 5, 2005 | Substantially Equivalent |
| K042878 | FLEXITIME XTREME | Dec 17, 2004 | Substantially Equivalent |
| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
| K040859 | HERACERAM PRESS | May 20, 2004 | Substantially Equivalent |
| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |