PRO-FLEX DISPOSABLE PROPHY ANGLE
FDA 510(k) clearance K981869 · decided 1998-08-11
Clearance details
- K-number
- K981869
- Device name
- PRO-FLEX DISPOSABLE PROPHY ANGLE
- Applicant
- Professional Dental Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-28
- Decision date
- 1998-08-11
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Batesville, AR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Professional Dental Mfg.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.