PINK CAD/CAM Disc

Resin, Denture, Relining, Repairing, Rebasing

POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY

The following data is part of a premarket notification filed by Polident D.o.o., Dental Products Industry with the FDA for Pink Cad/cam Disc.

Pre-market Notification Details

• Device ID: K153546
• 510k Number: K153546
• Device Name: PINK CAD/CAM Disc
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY VOLCJA DRAGA 42 Volcja Draga, SI 5293
• Contact: Janja Lipuscek
• Correspondent: Janja Lipuscek; POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY VOLCJA DRAGA 42 Volcja Draga, SI 5293
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-11
• Decision Date: 2016-09-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EPOLPMMP10161	K153546	000
EPOLPMMPML9940	K153546	000
EPOLPMMPML9930	K153546	000
EPOLPMMPML10290	K153546	000
EPOLPMMPML10280	K153546	000
EPOLPMMPML10270	K153546	000
EPOLPMMPML10260	K153546	000
EPOLPMMPML10530	K153546	000
EPOLPMMPML10520	K153546	000
EPOLPMMPML9950	K153546	000
EPOLPMMPML9960	K153546	000
EPOLPMMPML9970	K153546	000
EPOLPMMP10151	K153546	000
EPOLPMMP10141	K153546	000
EPOLPMMP10131	K153546	000
EPOLPMMP10121	K153546	000
EPOLPMMP10111	K153546	000
EPOLPMMP10101	K153546	000
EPOLPMMP10091	K153546	000
EPOLPMMPML9980	K153546	000
EPOLPMMPML10510	K153546	000
EPOLPMMPML10500	K153546	000
EPOLPMMPML10380	K153546	000
EPOLPMMPML10370	K153546	000
EPOLPMMPML10360	K153546	000
EPOLPMMPML10350	K153546	000
EPOLPMMPML10340	K153546	000
EPOLPMMPML10330	K153546	000
EPOLPMMPML10320	K153546	000
EPOLPMMPML10310	K153546	000
EPOLPMMPML10390	K153546	000
EPOLPMMPML10400	K153546	000
EPOLPMMPML10410	K153546	000
EPOLPMMPML10490	K153546	000
EPOLPMMPML10480	K153546	000
EPOLPMMPML10470	K153546	000
EPOLPMMPML10460	K153546	000
EPOLPMMPML10450	K153546	000
EPOLPMMPML10440	K153546	000
EPOLPMMPML10430	K153546	000
EPOLPMMPML10420	K153546	000
EPOLPMMPML10300	K153546	000
EPOLPMMP10171	K153546	000
EPOLPMMP67903	K153546	000
EPOLPMMP48103	K153546	000
EPOLPMMPML3571	K153546	000
EPOLPMMPML3561	K153546	000
EPOLPMMP7881	K153546	000
EPOLPMMP7871	K153546	000
EPOLPMMP7861	K153546	000
EPOLPMMP7851	K153546	000
EPOLPMMP7841	K153546	000
EPOLPMMP48203	K153546	000
EPOLPMMP48303	K153546	000
EPOLPMMP48403	K153546	000
EPOLPMMP66203	K153546	000
EPOLPMMP66003	K153546	000
EPOLPMMP49003	K153546	000
EPOLPMMP48903	K153546	000
EPOLPMMP48803	K153546	000
EPOLPMMP48703	K153546	000
EPOLPMMP48603	K153546	000
EPOLPMMP48503	K153546	000
EPOLPMMP7831	K153546	000
EPOLPMMP6791	K153546	000
EPOLPMMP4811	K153546	000
EPOLPMMP10251	K153546	000
EPOLPMMP10241	K153546	000
EPOLPMMP10231	K153546	000
EPOLPMMP10221	K153546	000
EPOLPMMP10211	K153546	000
EPOLPMMP10201	K153546	000
EPOLPMMP10191	K153546	000
EPOLPMMP4821	K153546	000
EPOLPMMP4831	K153546	000
EPOLPMMP4881	K153546	000
EPOLPMMP6781	K153546	000
EPOLPMMP6771	K153546	000
EPOLPMMP6751	K153546	000
EPOLPMMP6621	K153546	000
EPOLPMMP6601	K153546	000
EPOLPMMP5111	K153546	000
EPOLPMMP4901	K153546	000
EPOLPMMP4891	K153546	000
EPOLPMMP10181	K153546	000