FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
PROPHY ANGLE
K Number: K953628
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
7
Applicant Total
12
Review Days
60
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Basic Information
- Device Name
- PROPHY ANGLE
- K Number
- K953628
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6290
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rolence Enterprise Co. , Ltd.
- Date Received
- July 31, 1995
- Decision Date
- September 29, 1995
- Product Code
- EHK
- 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 |
|---|---|---|---|
| EHK | Cup, Prophylaxis | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHK), ordered by most recent decision date.
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PROPHYLAXIS CUPS AND POLISHERS
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PROPHY CUPS, R&R
FDA 510(k)
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| K991863 | CUTE-LITE I LIGHT CURE UNIT | Jul 19, 1999 | Substantially Equivalent |
| K980793 | Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT | May 15, 1998 | Substantially Equivalent |
| K980792 | CU-100A LIGHT CURE UNIT | May 15, 1998 | Substantially Equivalent |
| K960364 | CU-200 LIGHT CURE UNIT | Apr 15, 1996 | Substantially Equivalent |
| K960351 | Q-LUX LIGHT CURE UNIT | Apr 15, 1996 | Substantially Equivalent |
| K952423 | CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 | Jun 22, 1995 | Substantially Equivalent |
| K942199 | CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 | Jun 2, 1994 | Substantially Equivalent |
| K942198 | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 | May 27, 1994 | Substantially Equivalent |