RUBBER DAM HOLDER
FDA 510(k) clearance K781520 · decided 1978-10-10
Clearance details
- K-number
- K781520
- Device name
- RUBBER DAM HOLDER
- Applicant
- Young Dental Manufacturing Co. 1, LLC
- Decision
- Substantially Equivalent
- Date received
- 1978-09-01
- Decision date
- 1978-10-10
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- EJE
- Device class
- 1
- Regulation number
- 872.6300
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Young Dental Manufacturing Co. 1
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.
| Record | Firm | Date |
|---|---|---|
| HYGIENIC RUBBER DAM FRAME (K780746) | Hygienic Dental Mfg., Co., The | 1978-05-12 |
| HYGIENIC 5 & 6 RUBBER DAM FRAME (K770117) | Hygienic Dental Mfg., Co., The | 1977-01-28 |
Recalls involving this device
No recalls on record reference this clearance.