Identity
- Trade Name
- Burkhart Dental Supply FDA UDI
- Generic Name
- Dental surgical power tool motor, pneumatic FDA UDI
- Device Name
- Arete Hygienist Swivel Prophy Handpiece FDA UDI
- Model / Reference
- 72721977 FDA UDI
- Description
- Arete Hygienist Swivel Prophy Handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815878027499 FDA UDI
- 510(k) Number
- K083101 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental surgical power tool motor, pneumatic 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: Dental surgical power tool motor, pneumatic
Burkhart Dental Supply by Burkhart Dental Supply Co., The — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental surgical power tool motor, pneumatic.
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Cleared under the same submission
K083101 also covers:
- Burkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THE
- Access Prophy — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Hygienist Package — Sable Industries 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Burkhart Dental Supply Co., The
Sources (1)
- FDA UDI 24c73ffe-40dc-40dd-bdd0-ac80f2edc184 35 fields · synced May 30, 2026