FDA.reportPublic FDA data

SunMed

Primary DI
10889483231135
Brand
SunMed
Company
SUNMED, LLC
Model
TP-50-I
Catalog number
TP-50-I
Device description
TOOTH PROTECTOR INDIVIDUAL WRAPPED 50/PK
Published
2023-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BRWProtector, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889483231135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948323113510889483231135

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, single-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483222065VixOne™020502052025-12-19
10889483224533VixOne™022302232025-12-19
10889483230046VixOne™032503252025-12-19
10889483231234VixOne™023302332025-12-19
10889483495742Pedi-Neb™3655PN-6123655PN-6122025-12-19
10889483002742Mask Harness4-1054-222026-03-19
30889483631472AirLifeFC0010FC00102026-02-27
20889483033309SunMed09-0203-0609-0203-062026-02-18
20889483033316SunMed09-0203-1009-0203-102026-02-18
20889483033323SunMed09-0203-1409-0203-142026-02-18
20889483230005VixOne™031103112026-02-11
20889483300135Respan®R-8270R-82702026-02-11
30889483562615BALLARD™227-5227-52025-11-21
30889483563391BALLARD™12601126012025-11-19
30889483563681BALLARD™196812718681272025-11-19
30889483563711BALLARD™197812719781272025-11-19
30889483567030BALLARD™821582152025-11-19
30889483623316BALLARD™21603-4J21603-4J2025-11-21
30889483623323BALLARD™216036-4J216036-4J2025-11-21
30889483623347BALLARD™2160-4J2160-4J2025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017902302EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017900605EZ Bite blockDXM CO., LTDBRW2025-12-16
00194613123468MSI Precision Specialty InstrumentsMed Saver, Inc.BRW2025-08-01
08800142100949Tera Harz GuardGraphy Inc.BRW2025-07-18
00885797672278RMORmo, Inc.BRW2024-08-26
00885797672292RMORmo, Inc.BRW2024-08-26
00000008857972RMORmo, Inc.BRW2024-08-12
10889483007563SunMedSUNMED, LLCBRW2024-03-12
08800075604170OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604187OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604194OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
10630094199709Bioseal Inc.BIOSEALBRW2023-12-12
10630094199204Bioseal Inc.BIOSEALBRW2023-12-11
10630094199259Bioseal Inc.BIOSEALBRW2023-12-11
10630094199303Bioseal Inc.BIOSEALBRW2023-12-11
10630094199327Bioseal Inc.BIOSEALBRW2023-12-11
10630094199013Bioseal Inc.BIOSEALBRW2023-12-07
10630094199112Bioseal Inc.BIOSEALBRW2023-12-07
10630094199129Bioseal Inc.BIOSEALBRW2023-12-07
10630094199136Bioseal Inc.BIOSEALBRW2023-12-07
08800017900599EZ Bite blockDXM CO., LTDBRW2023-07-26
00723896020210FlexiProp Reusable Mouth Prop 2 PK Small PRACTICON, INC.BRW2023-06-08
00723896020241FlexiProp Reusable Mouth Prop 2 PK Medium PRACTICON, INC.BRW2023-06-08
00723896020272FlexiProp Reusable Mouth Prop 2 PK LargePRACTICON, INC.BRW2023-06-08
M63342818520JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-05-09
M63342818530JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-05-09
M63342818500JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-05-03
M63342818510JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-02-24
D72310297450Safco Mouth PropsSAFCO DENTAL SUPPLY CO.BRW2022-11-30