FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPACELINE THREE WAY SYRINGE
K Number: K801686
·
Decision Aug 4, 1980
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
11
Applicant Total
22
Review Days
14
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Basic Information
- Device Name
- SPACELINE THREE WAY SYRINGE
- K Number
- K801686
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pacific Dental Corp.
- Date Received
- July 21, 1980
- Decision Date
- August 4, 1980
- Product Code
- ECB
- 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 |
|---|---|---|---|
| ECB | Unit, Syringe, Air And/Or Water | FDA class 1 | Dental |
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Other Clearances by Pacific Dental Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K821782 | BEACH ANESTHETIC SYRINGE CARTR. TYPE | Jul 20, 1982 | Substantially Equivalent |
| K821783 | BEACH SILICATE FILLING & LINING APPLIC. | Jul 6, 1982 | Substantially Equivalent |
| K821790 | BEACH EXCAVATOR'S NO. 1 & NO. 2 | Jul 6, 1982 | Substantially Equivalent |
| K821789 | BEACH CURETTE NO. 2 AND NO. 3 T.G. | Jul 6, 1982 | Substantially Equivalent |
| K821784 | BEACH GINGIVAL RETRACTION INSTR. TYPE B | Jul 6, 1982 | Substantially Equivalent |
| K821777 | BEACH MOUTH MIRROR | Jul 6, 1982 | Substantially Equivalent |
| K821780 | BEACH EXPLORER NO. 23T.G. | Jul 6, 1982 | Substantially Equivalent |
| K821785 | BEACH AMALGAM CARVER | Jul 6, 1982 | Substantially Equivalent |
| K821779 | BEACH AMALGAM CARRIER, GUN TYPE | Jul 6, 1982 | Substantially Equivalent |
| K821788 | BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT | Jul 6, 1982 | Substantially Equivalent |