FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS
K Number: K935144
·
Decision Feb 4, 1994
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
24
Applicant Total
24
Review Days
99
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
- DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS
- K Number
- K935144
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dentauraum, Inc.
- Date Received
- October 28, 1993
- Decision Date
- February 4, 1994
- Product Code
- ECI
- 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 |
|---|---|---|---|
| ECI | Band, Elastic, Orthodontic | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ECI), ordered by most recent decision date.
POWER COINS GLOW IN THE DARK LIGATURES
FDA 510(k)
FDA Class 1
·Dental
GLENROE CHAIN
FDA 510(k)
FDA Class 1
·Dental
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
FDA 510(k)
FDA Class 1
·Dental
ORTHODONTIC ELASTOMERIC LAGATURE MODULE
FDA 510(k)
FDA Class 1
·Dental
ORTHODONTIC ELASTOMERIC TUBE/THREAD
FDA 510(k)
FDA Class 1
·Dental
ORTHODONTIC ELASTOMERIC CHAIN
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Dentauraum, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952870 | REMANIUM: CS & G-SOFT | Jul 27, 1995 | Substantially Equivalent |
| K952867 | REMANIUM:GM 700, GM 380, GM 800, GFH | Jul 27, 1995 | Substantially Equivalent |
| K952866 | REMATITAN TITANIUM | Jul 27, 1995 | Substantially Equivalent |
| K952865 | REMANIUM: 200,CS, 380, AND CD | Jul 26, 1995 | Substantially Equivalent |
| K952868 | DENTAURUM JACKET CROWN & ROOT POSTS | Jul 19, 1995 | Substantially Equivalent |
| K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | Feb 13, 1995 | Substantially Equivalent |
| K942666 | ORTHALGENAT IMPRESSION MATERIAL | Aug 10, 1994 | Substantially Equivalent |
| K936151 | EXTRAORAL HEADGEAR | Aug 1, 1994 | Substantially Equivalent |
| K942665 | ORTHOCENT: LIQUID AND POWDER | Jul 22, 1994 | Substantially Equivalent |
| K942668 | O-TRAY IMPRESSION TRAYS | Jul 22, 1994 | Substantially Equivalent |