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Ca 8:1 1600911-001

by Bien-Air Portugal, Unipessoal, Lda United States GUDID

Product code EFB

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberJ00716009110011 UDI-DIDate22 May 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
Ca 8:1
Generic Name
Dental power tool handpiece motorless component
Model / Reference
1600911-001
Primary DI / UDI-DI
J00716009110011
FDA Product Code
EFB
GMDN Term
Dental power tool handpiece motorless component
Device Class
Class I
Regulation Number
872.4200
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Bien-Air Portugal, Unipessoal, Lda

See all devices from Bien-Air Portugal, Unipessoal, Lda →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
Other properties (12)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI b5b45a86-0dae-4ef3-a37a-a9799e63cc23 34 fields · synced 23 Oct 2026