LEW MDI O-BALL COLLARED IMPLANT,

Implant, Endosseous, Root-form

PARK DENTAL RESEARCH CORP.

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,.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D7692711MOB0	K121707	000
D7692712CO0	K121707	000
D76927100	K121707	000
D7692216CO0	K121707	000
D76922140	K121707	000
D7692212CO0	K121707	000
D7692210CO0	K121707	000
D769MMRA0	K121707	000
D769204DL0	K121707	000
D7692714CO0	K121707	000
D76927160	K121707	000
D7692210MOB0	K121707	000
D7692710MOB0	K121707	000
D7692217MOB0	K121707	000
D7692216MOB0	K121707	000
D7692215MOB0	K121707	000
D7692214MOB0	K121707	000
D7692213MOB0	K121707	000
D7692212MOB0	K121707	000
D7692211MOB0	K121707	000
D769165DL0	K121707	000
D769IMCASE40	K121707	000
D769IM2011CO0	K121707	000
D769IM2010XO0	K121707	000
D769IM2010CO0	K121707	000
D769IM2517XO0	K121707	000
D769IM2517CO0	K121707	000
D769IM2515XO0	K121707	000
D769IM2513XO0	K121707	000
D769IM2513CO0	K121707	000
D769IM2011XO0	K121707	000
D769IM2013CO0	K121707	000
D769IM2013XO0	K121707	000
D769IM2515CO0	K121707	000
D769IM2511XO0	K121707	000
D769IM2510XO0	K121707	000
D769IM2510CO0	K121707	000
D769IM2017XO0	K121707	000
D769IM2017CO0	K121707	000
D769IM2015XO0	K121707	000
D769IM2015CO0	K121707	000
D769IM2511CO0	K121707	000
D769CASE40	K121707	000
D7692017CO0	K121707	000
D7692015XO0	K121707	000
D7692015CO0	K121707	000
D7692013XO0	K121707	000
D7692013CO0	K121707	000
D7692011XO0	K121707	000
D7692011CO0	K121707	000
D7692010XO0	K121707	000
D7692017XO0	K121707	000
D7692510CO0	K121707	000
D7692510XO0	K121707	000
D7692517XO0	K121707	000
D7692517CO0	K121707	000
D7692515XO0	K121707	000
D7692515CO0	K121707	000
D7692513XO0	K121707	000
D7692513CO0	K121707	000
D7692511XO0	K121707	000
D7692511CO0	K121707	000
D7692010CO0	K121707	000
D769CASE60	K121707	000
D7691812CO0	K121707	000
D7691810XO0	K121707	000
D7691810CO0	K121707	000
D7692717MOB0	K121707	000
D7692716MOB0	K121707	000
D7692715MOB0	K121707	000
D7692714MOB0	K121707	000
D7692713MOB130	K121707	000
D7691812XO0	K121707	000
D7691814XO0	K121707	000
D7691816CO0	K121707	000
D7693017MOB0	K121707	000
D7693016MOB0	K121707	000
D7693015MOB0	K121707	000
D7693014MOB0	K121707	000
D7693013MOB0	K121707	000
D7693012MOB0	K121707	000
D7693010MOB0	K121707	000
D7691816XO0	K121707	000
D7692712MOB0	K121707	000