FDA.reportPublic FDA data

DryShield

Primary DI
00850045062170
Brand
DryShield
Company
Solmetex, LLC
Model
BMD DS-SUP-300
Device description
Mouthpiece - Single Use - PEDO - 20 Pack
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYNMouthpiece, Saliva Ejector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045062170PrimaryGS10
00850045062125Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045062170008500450621708500450621700850045062170
00850045062125008500450621258500450621250850045062125

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction systemAn assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-216-5505sales@solmetex.com

Regulatory Flags#

DUNS number
958831349
Device count
20
DM exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045062064DryShieldBMD DS-MPX-0012022-12-07
00850045062071DryShieldBMD DS-MPP-0022022-12-07
00850045062088DryShieldBMD DS-MPS-0032022-12-07
00850045062095DryShieldBMD DS-MPM-0042022-12-07
00850045062101DryShieldBMD DS-MPL-0052022-12-07
00850045062187DryShieldBMD DS-SUS-4002022-12-07
00850045062194DryShieldBMD DS-SUM-5002022-12-07
00850045062200DryShieldBMD DS-SUL-6002022-12-07
00850045062217DryShieldBMD DS-SYS-0012022-12-07
00850045062224DryShieldBMD DS-SYS-0022022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840161311733Lingua-Fix® - Low-Volume Evacuator - 1 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311764SE Cushion - Saliva Ejector Cushion - 5 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311788Pink Petal™ - Saliva Ejector Holder - 3 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311801Mr. Thirsty® One-Step - High Volume Evacuator - Variety 3 Count Sample PZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
07615208584981Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208584998Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208543506Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
D9099002011ORTHO ARCHOrtho Arch Company IncDYN2025-09-15
00840456209158JMUJMU DENTAL, INCDYN2025-06-17
00860349001720SWIK Modular MouthpieceSaliva Management Systems, Inc.DYN2025-06-17
00860349001737SWIK Modular Extension TubingSaliva Management Systems, Inc.DYN2025-06-17
00840161310668Pink Petal™ - Saliva Ejector Holder - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2025-01-09
50732224005008Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224004988Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224005015Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224005022Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
TQ26SE2555020Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555120Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555220Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555320Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555420Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555520Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555600Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555720Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555820Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555920Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2556020Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2556120Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
00304040186527Henry ScheinHENRY SCHEIN, INC.DYN2024-09-19
00304040186534Henry ScheinHENRY SCHEIN, INC.DYN2024-09-19