FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAL CONNECTOR PRECISION ATTACHMENT
K Number: K912435
·
Decision Aug 28, 1991
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
23
Applicant Total
67
Review Days
86
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Basic Information
- Device Name
- DENTAL CONNECTOR PRECISION ATTACHMENT
- K Number
- K912435
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3165
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Metalor Dental USA Corp.
- Date Received
- June 3, 1991
- Decision Date
- August 28, 1991
- Product Code
- EGG
- 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 |
|---|---|---|---|
| EGG | Attachment, Precision, All | FDA class 1 | Dental |
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| K973372 | AUROFILM 2000 | Nov 26, 1997 | Substantially Equivalent |
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