FDA.reportPublic FDA data

Mouthguard, single-use

Definition
A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.
GUDID devices
19
Last updated
2025-08-11 14:17:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00194613123468MSI Precision Specialty InstrumentsMed Saver, Inc.40-22752025-08-01
00844505014403ApollOSGrace Medical, Inc.8002024-05-03
10889483007563SunMedSUNMED, LLC9-3041-032024-03-12
10630094199709Bioseal Inc.BIOSEAL19970/252023-12-12
10630094199303Bioseal Inc.BIOSEAL19930/102023-12-11
10630094199112Bioseal Inc.BIOSEAL19911/252023-12-07
10630094199129Bioseal Inc.BIOSEAL19912/252023-12-07
10630094199136Bioseal Inc.BIOSEAL19913/122023-12-07
10889483231135SunMedSUNMED, LLCTP-50-I2023-07-18
05060465560056Medasil teeth protectorSpiggle & Theis Medizintechnik GmbH50-252-002022-09-27
05060465562654Medasil teeth protectorSpiggle & Theis Medizintechnik GmbH50-250-002022-09-27
D810PCSD1698111The Original Clearsplint DiscASTRON DENTAL CORPORATIONPCSD162021-07-16
D810PCSD2095Z111The Original Clearsplint DiscASTRON DENTAL CORPORATIONPCSD952021-07-16
D810PCSD2098NS111The Original Clearsplint DiscASTRON DENTAL CORPORATIONPCSD98N2021-07-16
D810PCSD985111The Original Clearsplint DiscASTRON DENTAL CORPORATIONPCSD982021-07-16
30641043812130Tooth ProtectorMERCURY ENTERPRISES, INC.10-812-132020-08-04
00856824006083NAZORCAP Bite GuardNASORCAP MEDICAL INC18012018-03-25
00817518020655Sharn IncSharn AnesthesiaTP-1-50-I2018-10-10
50618029810323Toothette Oral CareSAGE PRODUCTS, LLC40002016-09-24