# K201412: BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bego Implant Systems GmbH & Co. KG
- Decided: Feb 18, 2021 after 266 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K844002 (1984). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180791: Straumann BLX Surgical Cassette, Institut Straumann AG (2018) Summary page 5.

## Indications for use
BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMADOS® PKTr 58357 are intended to store and organize the BEGO Semados® surgical instruments, insertion tools, drill stops and prosthetic instruments during both steam sterilization in an autoclave and implant/ prosthetic treatments. BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMADOS® PKTr 58357 are not intended on its own to maintain sterility; it is intended to be used with a legally marketed, validated, FDA-cleared sterilization pouch. Cycle Temperature Exposure Time Drying Time Fractioned pre-vacuum steam 132°C (270°F) 4 min 20 min Sterilization validations included the worst-case load configurations and has the maximum load including instruments for the following device models: Device Model Maximum load (wt), including instruments Type of Instruments BEGO SEMADOS® Tr 58350 476 g Surgical instruments, insertion tools BEGO Semados® Tr 58349 261 g Surgical instruments, insertion tools BEGO Semados® DSTr 58356 137 g Drill stops BEGO SEMADOS® PKTr 58357 220 g Insertion tools, prosthetic instruments Healthcare facilities should not exceed 25 pounds (BEGO Semados® Trays containment device + sterile pouch + surgical instruments/insertion tools/drill stop/prosthetic instruments). Sterilization validations included the worst-case load configurations of following lumen sizes and dimensions and has the maximum load for the following device models: Device Model Type of Lumen Number of lumens Sizes & Dimensions [mm] BEGO SEMADOS® Tr 58350 Drill holes 8 Ø1.2, L2.4 / Ø 1.2, L 6.8 / Ø 2.4-2.9, L 22.5/14.6 / Ø1.2, L6.8 Oval hole 1 2.3 x 2.0 BEGO Semados® Tr 58349 Drill holes 4 Ø1.2, L2.4 / Ø2.4, L16 Oval hole 1 2.3x2.0 BEGO Semados® DSTr 58356 Drill holes 25 Ø 2.6-5.1, L 6-12 BEGO SEMADOS® PKTr 58357 Drill holes 5 Ø 2.4, L16 / Ø 1.2, L 6.8 BEGO SEMADOS® Tr 58350, BEGO Semados® Tr 58349, BEGO Semados® DSTr 58356, BEGO SEMADOS® PKTr 58357 are offered in the following sizes: Device Model Dimensions [mm] BEGO SEMADOS® Tr 58350 188.1 x 138.7 x 61.5 BEGO Semados® Tr 58349 142.7 x 99.6 x 61 BEGO Semados® DSTr 58356 80 x 85 x 28 BEGO SEMADOS® PKTr 58357 140 x 80 x 25

Source page: https://510kreport.com/device/K201412
Methodology: https://510kreport.com/methodology