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evertis TBBCR5042R

by Shinhung MST Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806343920072 UDI-DI Date26 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
evertis
Generic name
Dental implant suprastructure kit
Model / reference
TBBCR5042R
Description
Bite Imp. Coping Φ5.0 G/H2.0 H4 Cross-fit RC/Straumann Used when taking impressions to make Straumann BLT prostheses.
Primary DI / UDI-DI
08806343920072
FDA product code
EGG
GMDN term
Dental implant suprastructure kit
Device class
Class I
Regulation number
872.3165
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental implant suprastructure kit

Other devices from Shinhung MST Co., Ltd.

  • Sola

    Class IIb

  • Sis

    Class IIa

  • Luna

    Class IIb

  • Sola

    Class IIb

  • Sola

    Class IIb

  • Luna

    Class IIb

See all devices from Shinhung MST Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (9)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No