FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE
K Number: K921601
·
Decision Jun 16, 1992
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
103
Review Days
74
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Basic Information
- Device Name
- ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE
- K Number
- K921601
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ultradent Products, Inc.
- Date Received
- April 3, 1992
- Decision Date
- June 16, 1992
- Product Code
- JES
- 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 |
|---|---|---|---|
| JES | Floss, Dental | FDA class 1 | Dental |
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IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
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JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS
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