The following data is part of a premarket notification filed by Park Dental Research Corp. with the FDA for Lew Mdi O-ball Collared Implant,.
| Device ID | K121707 |
| 510k Number | K121707 |
| Device Name: | LEW MDI O-BALL COLLARED IMPLANT, |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PARK DENTAL RESEARCH CORP. 2401 N Commerce St Ste B Ardmore, OK 73401 |
| Contact | Ronald Bulard |
| Correspondent | Ronald Bulard PARK DENTAL RESEARCH CORP. 2401 N Commerce St Ste B Ardmore, OK 73401 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-11 |
| Decision Date | 2012-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7692210MOB0 | K121707 | 000 |
| D7692716MOB0 | K121707 | 000 |
| D7692717MOB0 | K121707 | 000 |
| D7691810CO0 | K121707 | 000 |
| D7691810XO0 | K121707 | 000 |
| D7691812CO0 | K121707 | 000 |
| D7691812XO0 | K121707 | 000 |
| D7691814XO0 | K121707 | 000 |
| D7691816CO0 | K121707 | 000 |
| D7691816XO0 | K121707 | 000 |
| D7693010MOB0 | K121707 | 000 |
| D7693012MOB0 | K121707 | 000 |
| D7692715MOB0 | K121707 | 000 |
| D7692714MOB0 | K121707 | 000 |
| D7692211MOB0 | K121707 | 000 |
| D7692212MOB0 | K121707 | 000 |
| D7692213MOB0 | K121707 | 000 |
| D7692214MOB0 | K121707 | 000 |
| D7692215MOB0 | K121707 | 000 |
| D7692216MOB0 | K121707 | 000 |
| D7692217MOB0 | K121707 | 000 |
| D7692710MOB0 | K121707 | 000 |
| D7692711MOB0 | K121707 | 000 |
| D7692712MOB0 | K121707 | 000 |
| D7692713MOB130 | K121707 | 000 |
| D7693013MOB0 | K121707 | 000 |
| D7693014MOB0 | K121707 | 000 |
| D7692017XO0 | K121707 | 000 |
| D7692510CO0 | K121707 | 000 |
| D7692510XO0 | K121707 | 000 |
| D7692511CO0 | K121707 | 000 |
| D7692511XO0 | K121707 | 000 |
| D7692513CO0 | K121707 | 000 |
| D7692513XO0 | K121707 | 000 |
| D7692515CO0 | K121707 | 000 |
| D7692515XO0 | K121707 | 000 |
| D7692517CO0 | K121707 | 000 |
| D7692517XO0 | K121707 | 000 |
| D7692017CO0 | K121707 | 000 |
| D7692015XO0 | K121707 | 000 |
| D7693015MOB0 | K121707 | 000 |
| D7693016MOB0 | K121707 | 000 |
| D7693017MOB0 | K121707 | 000 |
| D769CASE60 | K121707 | 000 |
| D7692010CO0 | K121707 | 000 |
| D7692010XO0 | K121707 | 000 |
| D7692011CO0 | K121707 | 000 |
| D7692011XO0 | K121707 | 000 |
| D7692013CO0 | K121707 | 000 |
| D7692013XO0 | K121707 | 000 |
| D7692015CO0 | K121707 | 000 |
| D769CASE40 | K121707 | 000 |