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ESA ST Disposable Prophy Angle Soft Cup Box 100
FDA UDIClass I (US FDA UDI)
by Preventech
Identity
- Trade Name
- ESA ST Disposable Prophy Angle Soft Cup Box 100 FDA UDI
- Generic Name
- Dental polishing cup, single-use FDA UDI
- Device Name
- ESA ST Disposable Prophy Angle Soft Cup Box of 100 single use prophy angles for dental prophylaxis procedures FDA UDI
- Model / Reference
- 3300113 FDA UDI
- Description
- ESA ST Disposable Prophy Angle Soft Cup Box of 100 single use prophy angles for dental prophylaxis procedures FDA UDI
Identifiers
- Catalog Number
- 3300113 FDA UDI
- Primary DI / UDI-DI
- D0243300113 FDA UDI
- 510(k) Number
- K994024 FDA UDI
- FDA Product Code
- EGS FDA UDI
- GMDN Term
- Dental polishing cup, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental polishing cup, single-use
ESA ST Disposable Prophy Angle Soft Cup Box 100 by Preventech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental polishing cup, single-use.
- Premium Plus — Premium Plus International Limited · Class I
- ProFlare — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Premium Plus — Premium Plus International Limited · Class I
- ONEGLOSS — SHOFU DENTAL CORP. · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Premium Plus — Premium Plus International Limited · Class I
Cleared under the same submission
K994024 also covers:
- ESA MW Disposable Prophy Angle Firm Cup Box 100 — Preventech
- ESA MW Disposable Prophy Angle Soft Cup Box 100 — Preventech
- ESA MW Disposable Prophy Angle Taper Brush Box 100 — Preventech
- ESA MW Non Latex Disposable Prophy Angle Firm Cup Box 100 — Preventech
- ESA MW Non Latex Disposable Prophy Angle Soft Cup Box 100 — Preventech
- ESA ST Disposable Prophy Angle Firm Cup Box 100 — Preventech
- ESA ST Disposable Prophy Angle Taper Brush Box 100 — Preventech
- ESA ST Non Latex Disposable Prophy Angle Soft Cup Box 100 — Preventech
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Preventech
Sources (1)
- FDA UDI 4348a436-9384-4f19-92c8-e8daf9ac49e4 36 fields · synced May 30, 2026