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Yomi S YomiLink Bone (U) Assembly (UR) DRW-2772-02

by Neocis Inc GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810004900776 UDI-DIDate1 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Yomi S YomiLink Bone (U) Assembly (UR)
Generic Name
Dental stereotactic surgery system
Model / Reference
DRW-2772-02
Primary DI / UDI-DI
00810004900776
510(k) Number
FDA Product Code
PLV
GMDN Term
Dental stereotactic surgery system
Device Class
Class II
Regulation Number
872.4120
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K252376)

Show all (12)

Other devices from Neocis Inc

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No