FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAURUM SPACE MAINTAINER
K Number: K935856
·
Decision Apr 28, 1994
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
3
Applicant Total
24
Review Days
141
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Basic Information
- Device Name
- DENTAURUM SPACE MAINTAINER
- K Number
- K935856
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5525
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dentauraum, Inc.
- Date Received
- December 8, 1993
- Decision Date
- April 28, 1994
- Product Code
- DYT
- 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 |
|---|---|---|---|
| DYT | Maintainer, Space Preformed, Orthodontic | FDA class 1 | Dental |
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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 |