Identity
- Trade Name
- The Original Clearsplint Disc FDA UDI
- Generic Name
- Mouthguard, single-use FDA UDI
- Device Name
- Package of 1 disc 98mmX20mm with no shoulder FDA UDI
- Model / Reference
- PCSD98N FDA UDI
- Description
- Package of 1 disc 98mmX20mm with no shoulder FDA UDI
Identifiers
- Catalog Number
- PCSD98N FDA UDI
- Primary DI / UDI-DI
- D810PCSD2098NS111 FDA UDI
- 510(k) Number
- K111828 FDA UDI
- FDA Product Code
- MQC FDA UDI
- GMDN Term
- Mouthguard, single-use FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mouthguard, single-use
The Original Clearsplint Disc by Astron Dental — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Mouthguard, single-use.
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- Bioseal Inc. — BIOSEAL · Class I
- SunMed — SunMed · Class I
- Bioseal Inc. — BIOSEAL · Class I
Cleared under the same submission
K111828 also covers:
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
- CLEARSPLINT — Astron Dental
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Astron Dental
Sources (2)
- FDA UDI 7d8f2b26-69aa-4b7a-96fc-eab21e697d81 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 3, 2026