FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ATD AUTOMATIC BRIDGE REMOVER
K Number: K992649
·
Decision Oct 29, 1999
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
18
Applicant Total
52
Review Days
84
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Basic Information
- Device Name
- ATD AUTOMATIC BRIDGE REMOVER
- K Number
- K992649
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J. Morita USA, Inc.
- Date Received
- August 6, 1999
- Decision Date
- October 29, 1999
- Product Code
- EIS
- 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 |
|---|---|---|---|
| EIS | Remover, Crown | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EIS), ordered by most recent decision date.
EASY PNEUMATIC CROWN AND BRIDGE REMOVER
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STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
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HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER
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H-TYPE BRIDGE REMOVER
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SATIN CAST ECONOCAST
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C & B 40 PENTRO C & B40
FDA 510(k)
FDA Class 1
·Dental
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