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DryShield

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref DS-MPM-004Ref DS-SUP-300Ref DS-MPX-001Ref DS-MPP-002Ref DS-SUS-400Ref DS-SUM-500

by Solmetex, LLC

Identity

Trade Name
DryShield EUDAMEDFDA UDI
Generic Name
Dental suction system FDA UDI
Device Name
Dryshield Isolation System and Mouthpieces EUDAMED
Mouthpiece - Autoclave - X-PEDO - 4 Pack FDA UDI
Mouthpiece - Autoclave - PEDO - 4 Pack FDA UDI
Mouthpiece - Single Use - MEDIUM - 20 Pack FDA UDI
Mouthpiece - Single Use - PEDO - 20 Pack FDA UDI
Mouthpiece - Autoclave - MEDIUM - 4 Pack FDA UDI
Mouthpiece - Single Use - SMALL - 20 Pack FDA UDI
Model / Reference
DS-MPM-004 EUDAMED
DS-SUP-300 EUDAMED
DS-MPX-001 EUDAMED
DS-MPP-002 EUDAMED
DS-SUS-400 EUDAMED
DS-SUM-500 EUDAMED
BMD DS-MPX-001 FDA UDI
BMD DS-MPP-002 FDA UDI
BMD DS-SUM-500 FDA UDI
BMD DS-SUP-300 FDA UDI
BMD DS-MPM-004 FDA UDI
BMD DS-SUS-400 FDA UDI
Description
Mouthpiece - Autoclave - X-PEDO - 4 Pack FDA UDI
Mouthpiece - Autoclave - PEDO - 4 Pack FDA UDI
Mouthpiece - Single Use - MEDIUM - 20 Pack FDA UDI
Mouthpiece - Single Use - PEDO - 20 Pack FDA UDI
Mouthpiece - Autoclave - MEDIUM - 4 Pack FDA UDI
Mouthpiece - Single Use - SMALL - 20 Pack FDA UDI

Identifiers

Primary DI / UDI-DI
00850045062064 EUDAMEDFDA UDI
00850045062071 EUDAMEDFDA UDI
00850045062194 EUDAMEDFDA UDI
00850045062170 EUDAMEDFDA UDI
00850045062095 EUDAMEDFDA UDI
00850045062187 EUDAMEDFDA UDI
Basic UDI-DI
B-00850045062095 EUDAMED
B-00850045062170 EUDAMED
B-00850045062064 EUDAMED
B-00850045062071 EUDAMED
B-00850045062187 EUDAMED
B-00850045062194 EUDAMED
FDA Product Code
DYN FDA UDI
EMDN Code
Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
GMDN Term
Dental suction system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental suction system

DryShield by Solmetex, LLC — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental suction system.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Solmetex, LLC

Sources (12)

  • FDA UDI 3446d52d-06d4-4a06-be7d-2325f6a11c63 35 fields · synced Aug 4, 2026
  • FDA UDI 2e8b3c06-1de7-4fe5-b26d-7466b02ef96a 35 fields · synced May 29, 2026
  • FDA UDI 9b1521ee-e5ee-4ee3-9b98-206d8ae5aa41 35 fields · synced May 30, 2026
  • FDA UDI f8117018-193a-4784-9253-8de4b7a4b732 35 fields · synced May 30, 2026
  • FDA UDI 0cabd091-6a1f-4307-b714-783becd1edca 35 fields · synced May 30, 2026
  • FDA UDI 014ac120-82a5-4e58-8610-7827e41043b3 35 fields · synced May 30, 2026
  • EUDAMED a9b85294-53d6-4ea4-b0fe-b3183ad0c24d 61 fields · synced Jul 8, 2026
  • EUDAMED 663df426-fb07-468f-a3aa-2b553173a829 61 fields · synced Jul 10, 2026
  • EUDAMED 80ff1bfa-1ac1-4705-b783-67e07c4ef8d2 61 fields · synced Jul 20, 2026
  • EUDAMED 8b3c11b4-1a66-4b2f-8e22-47050636d9cf 61 fields · synced Jul 22, 2026
  • EUDAMED 7dad9338-5a0b-4ba9-b75a-72570f7d91e5 61 fields · synced Jul 24, 2026
  • EUDAMED bf2f3278-35ea-47f9-a881-f44a540d931a 61 fields · synced Aug 4, 2026