The following data is part of a premarket notification filed by Park Dental Research Corp. with the FDA for Star/vent Internal Hex Screw Implant.
| Device ID | K082800 |
| 510k Number | K082800 |
| Device Name: | STAR/VENT INTERNAL HEX SCREW IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PARK DENTAL RESEARCH CORP. 5335 WISCONSIN AVE. NW SUITE 440 Washington, DC 20015 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli PARK DENTAL RESEARCH CORP. 5335 WISCONSIN AVE. NW SUITE 440 Washington, DC 20015 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2010-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D769XP50160 | K082800 | 000 |
| D769P50130 | K082800 | 000 |
| D769P50110 | K082800 | 000 |
| D769P50100 | K082800 | 000 |
| D769P50080 | K082800 | 000 |
| D769P43130 | K082800 | 000 |
| D769P42160 | K082800 | 000 |
| D769P42110 | K082800 | 000 |
| D769P42100 | K082800 | 000 |
| D769P42080 | K082800 | 000 |
| D769P38160 | K082800 | 000 |
| D769P38130 | K082800 | 000 |
| D769P38110 | K082800 | 000 |
| D769P38100 | K082800 | 000 |
| D769P38080 | K082800 | 000 |
| D769P33160 | K082800 | 000 |
| D769P33110 | K082800 | 000 |
| D769P33100 | K082800 | 000 |
| D769P50160 | K082800 | 000 |
| D769XP33080 | K082800 | 000 |
| D769XP33100 | K082800 | 000 |
| D769XP50130 | K082800 | 000 |
| D769XP50110 | K082800 | 000 |
| D769XP50100 | K082800 | 000 |
| D769XP50080 | K082800 | 000 |
| D769XP42160 | K082800 | 000 |
| D769XP42130 | K082800 | 000 |
| D769XP42110 | K082800 | 000 |
| D769XP42100 | K082800 | 000 |
| D769XP42080 | K082800 | 000 |
| D769XP38160 | K082800 | 000 |
| D769XP38130 | K082800 | 000 |
| D769XP38110 | K082800 | 000 |
| D769XP38100 | K082800 | 000 |
| D769XP38080 | K082800 | 000 |
| D769XP33160 | K082800 | 000 |
| D769XP33130 | K082800 | 000 |
| D769XP33110 | K082800 | 000 |
| D769P33080 | K082800 | 000 |