Identity
- Trade Name
- Hygiene Direct FDA UDI
- Generic Name
- Pneumatic dental scaling/debridement system handpiece FDA UDI
- Device Name
- HYGIENE SELECT PETITE PRO PROPHY HP 5K PINK FDA UDI
- Model / Reference
- 135-1402 FDA UDI
- Description
- HYGIENE SELECT PETITE PRO PROPHY HP 5K PINK FDA UDI
Identifiers
- Catalog Number
- 135-1402 FDA UDI
- Primary DI / UDI-DI
- D77813514020 FDA UDI
- 510(k) Number
- K073652 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Pneumatic dental scaling/debridement system handpiece 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Pneumatic dental scaling/debridement system handpiece
Hygiene Direct by Scott's Dental Supply L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pneumatic dental scaling/debridement system handpiece.
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Cleared under the same submission
K073652 also covers:
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
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 |
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Manufacturer
- Manufacturer
- Scott's Dental Supply L.l.c.
Sources (1)
- FDA UDI a8bcb0c7-1fcd-4799-9c77-3ab0463300bc 36 fields · synced May 30, 2026