FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
K Number: K981516
·
Decision May 11, 1998
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
16
Review Days
13
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Basic Information
- Device Name
- STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
- K Number
- K981516
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sterngold/Implamed
- Date Received
- April 28, 1998
- Decision Date
- May 11, 1998
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Sterngold/Implamed
| K Number | Device Name | ||
|---|---|---|---|
| K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | Jan 8, 1999 | Substantially Equivalent |
| K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | Jan 8, 1999 | Substantially Equivalent |
| K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION | Nov 13, 1998 | Substantially Equivalent |
| K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | Oct 22, 1998 | Substantially Equivalent |
| K982895 | STERNOMEGA COMPOMER CEMENT | Oct 9, 1998 | Substantially Equivalent |
| K962326 | STERNGOLD BIO-5 (1127210) | Jul 24, 1996 | Substantially Equivalent |
| K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | Jul 24, 1996 | Substantially Equivalent |
| K962325 | QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) | Jul 24, 1996 | Substantially Equivalent |
| K962304 | STERNGOLD BIO-4 | Jul 23, 1996 | Substantially Equivalent |
| K962303 | STERNGOLD CF | Jul 18, 1996 | Substantially Equivalent |