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
40
Last updated
2026-06-05 06:05:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850298007034VENTIL-A Oral ProtectorSOMATICS, LLCVENT2026-05-27
00618029810328Toothette Oral CareSAGE PRODUCTS, LLC40002016-09-24
00630094199115Bioseal Inc.BIOSEAL19911/252023-12-07
00630094199122Bioseal Inc.BIOSEAL19912/252023-12-07
00630094199139Bioseal Inc.BIOSEAL19913/122023-12-07
00630094199306Bioseal Inc.BIOSEAL19930/102023-12-11
00630094199702Bioseal Inc.BIOSEAL19970/252023-12-12
04250676748188Endoragard teeth protectorSpiggle & Theis Medizintechnik GmbH50-240-002026-04-27
04250676748195Medasil teeth protectorSpiggle & Theis Medizintechnik GmbH50-250-002022-09-27
10641043812136Tooth ProtectorMERCURY ENTERPRISES, INC.10-812-132020-08-04
D810PCSD1695Z111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD1695Z12023-01-27
D810PCSD2095ZBESB111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2095ZBESB12023-01-27
D810PCSD2095ZBESM111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2095ZBESM12023-01-27
D810PCSD2098BESB111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2098BESB12023-01-27
D810PCSD2098BESM111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2098BESM12023-01-27
D810PCSD2595ZBES111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2595ZBES12023-01-27
D810PCSD2595ZBESB111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2595ZBESB12023-01-27
D810PCSD2595ZBESM111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2595ZBESM12023-01-27
D810PCSD2598BES111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2598BES12023-01-27
D810PCSD2598BESB111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2598BESB12023-01-27
D810PCSD2598BESM111CLEARSPLINTASTRON DENTAL CORPORATIONPCSD2598BESM12023-01-27
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, Inc.18012018-03-25
00817518020655Sharn IncSharn AnesthesiaTP-1-50-I2018-10-10
50618029810323Toothette Oral CareSAGE PRODUCTS, LLC40002016-09-24