Identity
- Trade Name
- Belmont X-Calibur Unit FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- Belmont X-Calibur Unit PMU WITH CUSPIDOR BOWL AND ASSISTANT FDA UDI
- Model / Reference
- Belmont X-Calibur Unit FDA UDI
- Description
- Belmont X-Calibur Unit PMU WITH CUSPIDOR BOWL AND ASSISTANT FDA UDI
Identifiers
- Catalog Number
- AU-XV2500C FDA UDI
- Primary DI / UDI-DI
- 04952195217311 FDA UDI
- 510(k) Number
- K000799 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
Yes
FDA UDI
Category: Dental delivery system
A reliable and efficient dental delivery system designed to provide patients with the necessary utilities and amenities for safe and effective treatment.
Similar devices
Also classified as Dental delivery system.
- Dental Unit — Lifedent (Zhuhai) Co., Ltd. · Class IIa
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- Forest — Ls Enterprises, Inc. · Class I
- Forest — Ls Enterprises, Inc. · Class I
- TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
- Forest — Ls Enterprises, Inc. · Class I
- A5 SINGLE CART — CEFLA s.c. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
Cleared under the same submission
K000799 also covers:
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
- Belmont X-Calibur Unit — TAKARA BELMONT CORP.
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
- Takara Belmont Corp.
Sources (1)
- FDA UDI d34c0b2b-1ba0-4ff1-b493-77f415c0ece6 36 fields · synced Jun 24, 2026