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Single Patient Flat Bottom Countersink Shaping Drill SPFCS386S

by ZimVie US Corp LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00844868052197 UDI-DIDate18 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  • Withdrawn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 23 Oct 2026.

Specification

GUDID

Trade Name
Single Patient Flat Bottom Countersink Shaping Drill
Generic Name
Fixture/appliance dental drill bit, single-use
Model / Reference
SPFCS386S
Primary DI / UDI-DI
00844868052197
FDA Product Code
NDP
GMDN Term
Fixture/appliance dental drill bit, single-use
Device Class
Class I
Regulation Number
872.3980
GUDID distribution status
In Commercial Distribution

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No