IMPREFLEX ALGINATE IMPRESSION MATERIAL
FDA 510(k) clearance K771120 · decided 1977-08-03
Clearance details
- K-number
- K771120
- Device name
- IMPREFLEX ALGINATE IMPRESSION MATERIAL
- Applicant
- Espe Dental Products
- Decision
- Substantially Equivalent
- Date received
- 1977-06-22
- Decision date
- 1977-08-03
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- LEW
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Espe Dental Products
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.
Recalls involving this device
No recalls on record reference this clearance.