FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENT-O-CRYL ORTHODONTIC ACRYLIC
K Number: K942667
·
Decision Feb 13, 1995
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
11
Applicant Total
24
Review Days
252
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Basic Information
- Device Name
- DENT-O-CRYL ORTHODONTIC ACRYLIC
- K Number
- K942667
- 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
- June 6, 1994
- Decision Date
- February 13, 1995
- Product Code
- KMY
- 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 |
|---|---|---|---|
| KMY | Positioner, Tooth, Preformed | 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 |
| 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 |
| K935856 | DENTAURUM SPACE MAINTAINER | Apr 28, 1994 | Substantially Equivalent |