FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYGIENIC ANCHORINGS
K Number: K780804
·
Decision Jun 14, 1978
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
24
Applicant Total
6
Review Days
34
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Basic Information
- Device Name
- HYGIENIC ANCHORINGS
- K Number
- K780804
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Hygienic Dental Mfg., Co., The
- Date Received
- May 11, 1978
- Decision Date
- June 14, 1978
- Product Code
- ECI
- 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 |
|---|---|---|---|
| ECI | Band, Elastic, Orthodontic | FDA class 1 | Dental |
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Other Clearances by Hygienic Dental Mfg., Co., The
| K Number | Device Name | ||
|---|---|---|---|
| K780745 | RUBBER DAM | May 12, 1978 | Substantially Equivalent |
| K780743 | CLAMP FORCEPS | May 12, 1978 | Substantially Equivalent |
| K780746 | HYGIENIC RUBBER DAM FRAME | May 12, 1978 | Substantially Equivalent |
| K780744 | BRINKER TISSUE RETRACTORS | May 12, 1978 | Substantially Equivalent |
| K770117 | HYGIENIC 5 & 6 RUBBER DAM FRAME | Jan 28, 1977 | Substantially Equivalent |