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PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box 144
FDA UDIClass I (US FDA UDI)
by Preventech
Identity
- Trade Name
- PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box 144 FDA UDI
- Generic Name
- Dental polishing cup, single-use FDA UDI
- Device Name
- PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box of 144 single use prophy angles for dental prophylaxis procedures FDA UDI
- Model / Reference
- 1133343 FDA UDI
- Description
- PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box of 144 single use prophy angles for dental prophylaxis procedures FDA UDI
Identifiers
- Catalog Number
- 1133343 FDA UDI
- Primary DI / UDI-DI
- D0241133343 FDA UDI
- 510(k) Number
- K951016 FDA UDI
- FDA Product Code
- EHK FDA UDI
- GMDN Term
- Dental polishing cup, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6290 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
PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box 144 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
K951016 also covers:
- PIVOT Coarse Adult Variety Prophy Pack Box 100 — Preventech
- PIVOT Coarse Kid's Variety Prophy Pack Box 100 — Preventech
- PIVOT Coarse Mint Prophy Pack Box 100 — Preventech
- PIVOT Extra Coarse Mint Prophy Pack Box 100 — Preventech
- PIVOT Fine Cherry Prophy Pack Box 100 — Preventech
- PIVOT Medium Adult Variety Prophy Pack Box 100 — Preventech
- PIVOT Medium Bubblegum Prophy Pack Box 100 — Preventech
- PIVOT Medium Kid's Variety Prophy Pack Box 100 — Preventech
- PIVOT Medium Mint Prophy Pack Box 100 — Preventech
- PIVOT Nada Pumice Paste Prophy Pack Box 100 — Preventech
- PIVOT Non-Latex Contra Disposable Prophy Angle Firm Cup Box 144 — Preventech
- PIVOT Non-Latex Contra Disposable Prophy Angle Soft Cup Box 144 — 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 277e0ae1-d064-4786-98c8-9f7559122ce8 36 fields · synced Jun 1, 2026