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PIVOT Coarse Mint Prophy Pack Box 100
FDA UDIClass I (US FDA UDI)
by Preventech
Identity
- Trade Name
- PIVOT Coarse Mint Prophy Pack Box 100 FDA UDI
- Generic Name
- Dental polishing cup, single-use FDA UDI
- Device Name
- PIVOT Coarse Mint Prophy Pack Box of 100 units each containing 1 PIVOT Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of NEXT Coarse Mint Prophy Paste FDA UDI
- Model / Reference
- 1100083 FDA UDI
- Description
- PIVOT Coarse Mint Prophy Pack Box of 100 units each containing 1 PIVOT Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of NEXT Coarse Mint Prophy Paste FDA UDI
Identifiers
- Catalog Number
- 1100083 FDA UDI
- Primary DI / UDI-DI
- D0241100083 FDA UDI
- FDA Product Code
- EHK FDA UDIEJR FDA UDI
- GMDN Term
- Dental polishing cup, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6290 FDA UDI872.6030 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: DentifriceDental polishing cup, single-use
PIVOT Coarse Mint Prophy Pack 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
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- 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
K100539 also covers:
- MAXMIN Coarse Bubblegum Prophy Paste with NuFluor Box 200 — Preventech
- MAXMIN Coarse Cherry Prophy Paste with NuFluor Box 200 — Preventech
- MAXMIN Coarse Mint Prophy Paste with NuFluor Box 200 — Preventech
- MAXMIN Coarse Orange Vanilla Prophy Paste with NuFluor Box 200 — Preventech
- MAXMIN Medium Bubblegum Prophy Paste with NuFluor Box 200 — Preventech
- MAXMIN Medium Cherry Prophy Paste with NuFluor Box 200 — Preventech
- MAXMIN Medium Mint Prophy Paste with NuFluor Box 200 — Preventech
- MAXMIN Medium Orange Vanilla Prophy Paste with NuFluor Box 200 — Preventech
- NEXT Coarse Adult Variety Prophy Paste Box 200 — Preventech
- NEXT Coarse Bubblegum Prophy Paste Box 200 — Preventech
- NEXT Coarse Cherry Prophy Paste Box 200 — Preventech
- NEXT Coarse Chocolate Mint Prophy Paste Box 200 — Preventech
K951016 also covers:
- PIVOT Coarse Adult Variety Prophy Pack Box 100 — Preventech
- PIVOT Coarse Kid's Variety 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
- PIVOT Non-Latex Disposable Prophy Angle Firm 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 b58aa652-5680-4366-9f8e-d2d0c55b6a07 36 fields · synced Jun 6, 2026