The following data is part of a premarket notification filed by Texapol Corp. with the FDA for Dental Plastic Bite Fork.
Device ID | K892373 |
510k Number | K892373 |
Device Name: | DENTAL PLASTIC BITE FORK |
Classification | Articulators |
Applicant | TEXAPOL CORP. 117 MIKRON RD. Bethlehem, PA 18017 |
Contact | R Levandoski |
Correspondent | R Levandoski TEXAPOL CORP. 117 MIKRON RD. Bethlehem, PA 18017 |
Product Code | EJP |
CFR Regulation Number | 872.3150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-06 |
Decision Date | 1989-06-12 |